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Ethics approval and consent to participate | DER | The study complies with the principles laid down in the Declaration of Helsinki and has been approved by the ethics committee of the Medical Association Berlin (Berlin—Ethik-Kommission der Ärztekammer Berlin). The reference number is Eth-27/10, it has been retrospectively registered at the WHO-approved registry German ... | PMC9990362 | |
Consent for publication | Approved for submission by all the named authors. | PMC9990362 | ||
Competing interests | FS reports grants from Helixor Heilmittel GmbH (travel costs and honoraria for speaking), grants from AstraZeneca (travel costs and honoraria for speaking), grants from Abnoba GmbH, and grants from Iscador AG, outside the submitted work. DS reports grants from the foundations Rut und Klaus Bahlsen Stiftung and the Förd... | PMC9990362 | ||
References | PMC9990362 | |||
Background | nonobstructive coronary arteries | MYOCARDIAL INFARCTION (MI) | The pathobiology of myocardial infarction (MI) with nonobstructive coronary arteries (MINOCA) is often uncertain. Investigating biomarker concentrations and their changes may offer novel pathophysiological insights. | PMC9973579 |
Methods and Results | obstructive (stenosis, obstructive coronary artery disease | REGRESSION, CORONARY ARTERY DISEASE | In this post hoc study of the PLATO (Platelet Inhibition and Patient Outcomes) trial, concentrations of hs‐cTnT (high‐sensitivity cardiac troponin T), NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide), hs‐CRP (high‐sensitivity C‐reactive protein), and GDF‐15 (growth differentiation factor 15) were measured in patie... | PMC9973579 |
Conclusions | myocardial injury, obstructive coronary artery disease | MYOCARDIAL DYSFUNCTION | Biomarker concentrations suggest greater initial inflammatory activity, similar degree of myocardial dysfunction, and less pronounced myocardial injury during the acute phase of MINOCA compared with MI with obstructive coronary artery disease but also faster myocardial recovery. | PMC9973579 |
Registration | URL: | PMC9973579 | ||
Subject Categories | Supplemental Material is available at For Sources of Funding and Disclosures, see page 13.*The PLATO Trial Investigators are listed in the supplement. | PMC9973579 | ||
Nonstandard Abbreviations and Acronyms | nonobstructive coronary, arteriesPlatelet, Myocardial Infarction | MYOCARDIAL INFARCTION, MYOCARDIAL INFARCTION | growth differentiation factor 15geometric mean ratiohigh‐sensitivity cardiac troponin Tmyocardial infarction with nonobstructive coronary arteriesPlatelet Inhibition and Patient OutcomesStockholm Myocardial Infarction With Normal Coronaries
| PMC9973579 |
Clinical Perspective | PMC9973579 | |||
What Is New? | myocardial damage, nonobstructive coronary arteries, obstructive coronary artery disease, inflammation, myocardial affection | MYOCARDIAL DYSFUNCTION, INFLAMMATION, MYOCARDIAL INFARCTION (MI) |
The present study is the first to examine temporal changes in established biomarkers of inflammation and myocardial damage/dysfunction in myocardial infarction (MI) with nonobstructive coronary arteries.Biomarkers indicate differences in pathobiology between patients with MI with nonobstructive coronary arteries and M... | PMC9973579 |
What Are the Clinical Implications? | myocardial damage, inflammation, hypoxia, nonobstructive coronary arteries | INFLAMMATION, HYPOXIA, PATHOPHYSIOLOGY, MYOCARDIAL DYSFUNCTION, OXIDATIVE STRESS |
Our results aid in understanding the pathophysiology of MI with nonobstructive coronary arteries and highlight processes that may be further explored on patient management.Around 5% to 10%Studies investigating the mechanisms behind MINOCA have relied on assessment of clinical risk factors, noninvasive myocardial imagi... | PMC9973579 |
METHODS | The data set analyzed in this study is not publicly available because of ethical restrictions. However, access can be made available at Uppsala Clinical Research Center (Uppsala, Sweden) upon reasonable request and under the provision that the data are accessed on site and do not leave Uppsala University. | PMC9973579 | ||
Study Population | This is an observational post hoc study of patients included in the PLATO (Platelet Inhibition and Patient Outcomes) trial ( | PMC9973579 | ||
Inclusion of patients into groups with MINOCA and MI‐CAD. | CAD, nonobstructive coronary arteries, obstructive coronary artery disease | CAD, MYOCARDIAL INFARCTION, CORONARY ARTERY DISEASE, ACUTE CORONARY SYNDROME | ACS indicates acute coronary syndrome; CAD, coronary artery disease; hs‐cTnT, high‐sensitivity cardiac troponin T; MI‐CAD, myocardial infarction with obstructive coronary artery disease; MINOCA, myocardial infarction with nonobstructive coronary arteries; and PLATO, Platelet Inhibition and Patient Outcomes.The PLATO tr... | PMC9973579 |
Definitions | coronary stenosis, NSTEMI, obstructive coronary artery disease | CORONARY STENOSIS, STENOSES | The final diagnosis of MI together with the presence of ST‐segment–elevation MI (STEMI) or non–ST‐segment–elevation MI (NSTEMI) was determined at discharge by the investigators at each trial site. There was no formal adjudication of the index diagnoses. Patients were deemed to have MINOCA when diagnosed as MI but witho... | PMC9973579 |
Biomarker Analysis | Plasma was collected by venous puncture at baseline (a median of 15.1 and 8.9 hours from onset of symptoms for patients with MINOCA and MI‐CAD, respectively) and after 1 month in a subset of paired patients and stored in aliquots in −70 °C until analysis. Baseline blood samples were obtained in all patients before coro... | PMC9973579 | ||
Statistical Analysis | diabetes, chronic kidney disease, dyslipidemia | ISCHEMIC STROKE, PERIPHERAL VASCULAR DISEASE, DYSLIPIDEMIA, REGRESSION, HEART FAILURE, HYPERTENSION, DIABETES | Categorical variables were reported as frequencies and percentages, and continuous variables were reported as medians with interquartile ranges. Distributions of biomarker concentrations were displayed in empirical cumulative distribution function plots.Differences in biomarker concentration distributions between MINOC... | PMC9973579 |
RESULTS | NSTEMI, nonobstructive coronary arteries, obstructive coronary artery disease | BLOOD, MYOCARDIAL INFARCTION | Biomarker results were available at baseline in 554 patients with MINOCA and 11 106 patients with MI‐CAD; at 1‐month follow‐up, biomarker results were available in 107 patients with MINOCA and 2755 patients with MI‐CAD (Figure Baseline Characteristics in Patients With MINOCA and MI‐CADData presented as numbers (with pe... | PMC9973579 |
Adjusted spline models illustrating the association of mean biomarker concentrations with time in patients with MINOCA and MI‐CAD divided on STEMI or NSTEMI status. | PMC9973579 | |||
Biomarker Concentrations at Baseline and Short‐Term Changes | chronic kidney disease, nonobstructive coronary arteries, obstructive coronary artery disease, dyslipidemia, heart failure, diabetes | MYOCARDIAL INFARCTION, ISCHEMIC STROKE, PERIPHERAL VASCULAR DISEASE, DYSLIPIDEMIA, REGRESSION, HEART FAILURE, HYPERTENSION, DIABETES | Baseline concentrations of hs‐cTnT, NT‐proBNP, hs‐CRP, and GDF‐15 in the total cohort of patients with MINOCA and MI‐CAD are presented in Table Biomarker Concentrations and Multiple Linear Regression Results in the Total Cohort at BaselineInflammationOxidative stressHypoxiaBiomarker data presented as medians (with inte... | PMC9973579 |
Biomarker Concentrations at 1‐Month Follow‐Up and Long‐Term Changes Over Time | chronic kidney disease, nonobstructive coronary arteries, obstructive coronary artery disease, dyslipidemia, heart failure, diabetes | MYOCARDIAL INFARCTION, ISCHEMIC STROKE, PERIPHERAL VASCULAR DISEASE, DYSLIPIDEMIA, REGRESSION, HEART FAILURE, HYPERTENSION, DIABETES | One‐month biomarker concentrations in the follow‐up cohort are given in Table Biomarker Concentrations and Multiple Linear Regression Results in the Follow‐Up Cohort at 1 Month After the MIInflammationOxidative stressHypoxiaBiomarker data presented as medians (with interquartile ranges). Model 1: adjusted for randomize... | PMC9973579 |
Temporal changes in biomarker concentrations from baseline to 1 month later in the follow‐up cohort of patients with MINOCA and MI‐CAD. | PMC9973579 | |||
DISCUSSION | myocardial damage, inflammation, myocardial affection, myocardial injury | INFLAMMATION, DYSFUNCTION | This is the first study examining temporal changes in established biomarkers of inflammation and myocardial damage and dysfunction in patients with MINOCA compared with MI‐CAD. Biomarkers were measured in the acute phase of the index MI and 1 month later in a follow‐up cohort, and careful consideration was taken of var... | PMC9973579 |
Differences in Biomarker Concentrations in the Acute Phase of | NSTEMI, myocardial injury | ADVERSE EVENTS, OTHER CARDIOVASCULAR DISEASE | In the acute phase, the adjusted linear model showed higher hs‐cTnT concentrations in patients with MI‐CAD compared with MINOCA, indicating a greater degree of myocardial injury in those with MI‐CAD. Indeed, numericallyNT‐proBNP concentrations in patients with MINOCA were similar to patients with MI‐CAD, except for pat... | PMC9973579 |
Biomarker Concentrations at 1 Month After the Index | Myocardial Infarction, myocardial injury | MYOCARDIAL INFARCTION, DYSFUNCTION, ACUTE CORONARY SYNDROME | The notion of a more favorable pathophysiological response in patients with MINOCA compared with MI‐CAD was supported by 1‐month biomarker concentrations and their changes from the acute phase of MI. More pronounced decreases for hs‐cTnT, NT‐proBNP, and hs‐CRP were noted in patients with MINOCA. At 1‐month follow‐up, c... | PMC9973579 |
Strengths and Limitations | The present study has several strengths. First, the study population was obtained from the PLATO trial, a large randomized control trial in which patients were carefully included and monitored. Second, we studied an international cohort with MINOCA, because the PLATO trial included patients from 862 centers in 43 count... | PMC9973579 | ||
CONCLUSIONS | myocardial damage | MYOCARDIAL DYSFUNCTION | The concentrations and temporal changes of hs‐cTnT, NT‐proBNP, hs‐CRP, and GDF‐15 at the index MI and 1 month later suggest differences in the pathobiology between MINOCA and MI‐CAD. Our data indicate greater initial inflammatory activity, similar degree of myocardial dysfunction, and less pronounced myocardial damage ... | PMC9973579 |
Sources of Funding | The present study was supported by the Swedish Foundation for Strategic Research (RB13‐0197) and Swedish Association of Local Authorities and Regions. The PLATO (Platelet Inhibition and Patient Outcomes) trial and the biomarker analyses were sponsored by AstraZeneca. The authors are solely responsible for the design an... | PMC9973579 | ||
Disclosures | Dr Giannitsis reports grants and personal fees from Roche Diagnostics and Daiichi Sankyo; personal fees from Bayer Vital, Boehringer Ingelheim, AstraZeneca, BRAHMS Deutschland, Novo Nordisk, Idorsia, Radiometer, and Mitsubishi Chemicals, outside the submitted work. Dr Budaj reports personal fees and nonfinancial suppor... | PMC9973579 | ||
Supporting information | Data S1Table S1Figure S1–S2Click here for additional data file. | PMC9973579 | ||
Acknowledgments | We thank the patients who participated in the PLATO (Platelet Inhibition and Patient Outcomes) trial and the investigators for their efforts. All principal investigators are listed in the supplemental material. | PMC9973579 | ||
References | PMC9973579 | |||
1. Introduction | psychological distress, human mood | The rice endosperm protein (REP) hydrolysate containing the following rice endosperm protein derived oligopeptides QQFLPEGQSQSQK, LPEGQSQSQK, and pEQFLPEGQSQSQK (a Rice (REP accounting for approximately 5% of rice endosperm is not only nutritionally important but also shows various physiological functions such as anti-... | PMC10421398 | |
2. Materials and Methods | PMC10421398 | |||
2.1. Study Design | This study was performed with a randomized, double-blind, and placebo-controlled design. Study 1 and Study 2 were conducted to evaluate our hypothesis of whether the intake of rice endosperm protein hydrolysate improved the negative mood status of humans when consumed only once (Study 1) and once a day for 4 weeks (Stu... | PMC10421398 | ||
2.1.1. Study 1 | Participants visited the study facility on the first test day. After a health check, the Profile of Mood Status 2nd edition for adults (POMS 2) [The animal study indicated that the positive effect of REP hydrolysate might be observed in a short time. Namely, the administration of REP hydrolysate shortened the immobile ... | PMC10421398 | ||
2.1.2. Study 2 | insomnia, Insomnia | EVENTS | Participants completed the POMS 2 and the Euthymia Scale on the third pre-examination day and completed the Insomnia Severity Index (ISI), which is a self-rating questionnaire to assess the subjective severity of insomnia, on the first day of the test food period as baseline evaluations. Participants answered the POMS ... | PMC10421398 |
2.2. Procedure | All study procedures were reviewed and approved by the Ethics Committee of Medical Station Clinic (IRB no. 20000022, 8 July 2021) and were conducted in accordance with the criteria set by the declaration of Helsinki. The trial was preregistered at the UMIN Clinical Trial Registry (no. UMIN000045037). Throughout the ent... | PMC10421398 | ||
2.3. Participants | allergic, malignant tumor, Depression, allergic reactions, Fatigue | MALIGNANT TUMOR, REMISSION, ALLERGIC REACTION | Two hundred fifty-one potential participants were informed verbally and documentarily of this study and signed an informed consent form before participation. These candidates went through the following pre-examination sessions. In total, 76 subjects who were healthy and eligible to participate in this study based on th... | PMC10421398 |
2.4. Test Foods | The REP hydrolysate was manufactured by Kameda Seika Co., Ltd. (Niigata, Japan). A tablet type food containing REP hydrolysate (25 mg/each) was used as the active food for the REP hydrolysate group. Two tablets were administered per day. Participants were taught to take the daily dosage at once. The concentration of th... | PMC10421398 | ||
2.5. Measurements | PMC10421398 | |||
2.5.1. Subjective Mood State Questionnaire | TMD, euthymia, Anxiety, mood disturbance, Hostility, Anger, Depression, Confusion, Fatigue | The psychological status was assessed with the following validated questionnaires: the Profile of Mood Status 2nd edition short form for adults (POMS 2) and the Euthymia Scale. POMS 2 is a self-reported questionnaire that assesses mood. It has two categories: the negative mood state and the positive mood state. The neg... | PMC10421398 | |
2.5.2. Subjective Sleep Quality Evaluation | insomnia, Insomnia | The Insomnia Severity Index (ISI) is a questionnaire that measures the subjective severity of insomnia. A higher score indicates more severe insomnia. The reliability and validity of the Japanese version of the ISI were previously confirmed [ | PMC10421398 | |
2.5.3. Measurements of Salivary CgA Concentrations | CgA | SHIGA | Saliva was collected with a swab and centrifuge tubes. Collected saliva samples were stored at −80 °C until measurement. The concentration of the salivary Chromogranin A (CgA) was determined with a commercially available human CgA EIA kit (Yanaihara Institute Inc., Shizuoka, Japan). The total protein in the saliva samp... | PMC10421398 |
2.6. Outcomes | PMC10421398 | |||
2.6.1. Study 1 | SECONDARY | The primary outcome for study 1 was the POMS 2 scores (AH, CB, DD, FI, TA, VA, F, and TMD). The secondary outcome was the Euthymia Scale score and salivary CgA concentration. | PMC10421398 | |
2.6.2. Study 2 | SECONDARY | The primary endpoint was the change in the Euthymia Scale scores from the baseline to the fourth week of intervention. The secondary outcomes were the POMS 2 and ISI scores. | PMC10421398 | |
2.7. Sample Size Calculation | Based on the results of the previous clinical trial (Clinical Trial Registry no. UMIN 000041724), a total of 66 participants was calculated to be necessary to detect a difference of 1.27, with 1.7 standard deviations in the Euthymia Scale between the REP hydrolysate group and the placebo group with a two-sided signific... | PMC10421398 | ||
2.8. Randomization and Blinding | A person in charge of allocation randomly allocated the participants to the REP hydrolysate arm or the placebo arm with the block randomization method. A computationally generated random allocation sequence was used. The block size of the RCT was set to 4. The allocation factors were the POMS 2 score of the FI and VA a... | PMC10421398 | ||
2.9. Statistical Analyses | The results are shown as the mean ± standard error of the mean (SEM). For Study 1, the changes before and after the intake of test food were evaluated. For Study 2, the changes from the baseline to the fourth week were evaluated. The independent | PMC10421398 | ||
3. Results | The participants’ enrollment in this study is described in | PMC10421398 | ||
3.1. Study 1 | PMC10421398 | |||
3.1.2. Salivary CgA Concentrations (Post Hoc) | CgA | As a subjective mood improvement was observed in Study 1, the salivary concentration of CgA was conducted as a post hoc analysis. CgA concentrations were evaluated in 66 of the 76 participants (placebo, | PMC10421398 | |
3.2. Study 2 | PMC10421398 | |||
4. Discussion | mental disorder, Anxiety, daytime disturbance | This study was conducted to confirm the effect of the single intake and repeated intake of REP hydrolysate on the subjective mood. The single intake of REP hydrolysate significantly improved the POMS 2 subscale of Tension–Anxiety (The single intake of REP hydrolysate showed a significant improvement in the POMS 2 Tensi... | PMC10421398 | |
5. Conclusions | Anxiety, anxiety, nervousness | ADVERSE EFFECTS | In the present study, the 4-week intake of REP hydrolysate did not show a positive effect, possibly due to the insufficient length of intervention. The single intake of REP hydrolysate did not improve the Euthymia Scale or all of the subscales of POMS 2; yet, it showed a significant improvement in the POMS 2 Tension–An... | PMC10421398 |
Author Contributions | Conceptualization, R.N., A.I., K.U., Y.H. and H.T.; methodology, R.N., D.N. and Y.H.; data curation, R.N. and Y.H.; writing—original draft preparation, R.N.; writing—review and editing, D.N., M.S. and K.O.; visualization, R.N.; supervision, D.N.; project administration, H.T. and K.O.; funding acquisition, A.I. and K.O.... | PMC10421398 | ||
Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Medical Station Clinic (IRB no. 20000022, 8 July 2021). | PMC10421398 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10421398 | ||
Data Availability Statement | Not applicable. | PMC10421398 | ||
Conflicts of Interest | R.N., Y.H., K.U., A.I. and H.T. are the employees of Kameda Seika Co., Ltd. or the study’s sponsor. The other authors declare no conflict of interest in association with the present study. | PMC10421398 | ||
References | Anxiety, Insomnia, Hostility, Anger, Depression, Confusion, Fatigue | Flow diagram for study participants’ eligibility, enrollment, and followup.Background characteristics of participants.POMS, Profile of Mood Status; FI, Fatigue–Inertia; VA, Vigor–Activity. Values for the POMS 2 and Euthymia Scale were measured at the third pre-examination point. Other values were measured at the first ... | PMC10421398 | |
1. Introduction | Saudi, injuries | COMMUNICABLE DISEASES | Encouraging physical activity (PA) for adolescents is necessary to achieve and maintain optimal health, but it may increase the risk of PA-related injuries. This study sought to assess the frequency, location, type, and severity of PA-related injuries in Saudi students aged 13 to 18 years and to identify associated ris... | PMC10001543 |
2. Methods | PMC10001543 | |||
2.1. Participants | disapproval, overweight | OBESE | According to the Saudi Ministry of Education—General Education Statistics at The positive responses received concerned 410 students (210 boys and 200 girls), while the others refused to participate. The disapproval was mainly attributed to cultural reasons that discourage participation in such studies. Before the measu... | PMC10001543 |
2.2. Procedures and Ethics | This study was conducted between September 2022 and November 2022 in accordance with the Declaration of Helsinki (rev. 2013) relating to the ethical principles for medical research involving human subjects [Prior to the measurements, participants and their parents were invited to a meeting with the research team to be ... | PMC10001543 | ||
2.3. Measurements | PMC10001543 | |||
2.3.1. Anthropometric Parameters | For each participant, height was measured using a stadiometer (Holtain, Crymych, Wales, UK), and weight, BMI, and fat percentage were determined using bioelectrical impedance with a body composition monitor (Omron, Body Composition Monitor BF 508, Kyoto, Japan). | PMC10001543 | ||
2.3.2. Physical Activity-Related Injuries Parameters | COMPLICATIONS | Based on a questionnaire from the work of Wang and Huang [An acceptable PA-related injury must have met at least one of the following criteria: the student (1) must stop the current PA; (2) cannot participate in the next scheduled PA; (3) cannot go to class the next day; (4) should seek medical attention (including fir... | PMC10001543 | |
2.3.3. Parameters Related to Physical Activity | The assessment was conducted using the Arabic version of the Physical Activity Questionnaire for adolescents (PAQ-A) [To be easily understood by all participants, the English version of the PAQ-A has been translated and adapted to the Saudi context following the recommendations of Beaton et al. [ | PMC10001543 | ||
2.3.4. Parameters Related to Sedentary Behaviors | Evaluated using the NSW Schools Physical Activity and Nutrition Survey [ | PMC10001543 | ||
2.3.5. Reliability and Validity of PAQ-A | The exploratory factor and principal component analysis results indicate that the Kaiser–Meyer–Olkin measure of sampling adequacy was 0.697, which is above the acceptable 0.6 threshold. The Bartlett’s test sphericity score was statistically significant ( | PMC10001543 | ||
2.4. Statistical Analysis | The descriptive analysis of the sample and variables was conducted with the calculation of means, standard deviations, and frequencies. The normality of the distributions was tested using histograms and absolute values of skewness and kurtosis. An absolute skew value greater than 2 or an absolute kurtosis greater than ... | PMC10001543 | ||
3. Results | PMC10001543 | |||
3.1. Sample Characteristics | injuries, fractures, fat-free mass | A total of 402 students completed all the parts of the study and were analyzed. Of these, 196 were girls (48.76%) aged 15.83 ± 1.7 years, and 206 were boys (51.24%) aged 15.87 ± 1.69 years. Referring to the sex-specific BMI-for-age percentile charts, the overall prevalence of overweight and obesity in boys was 11.7% an... | PMC10001543 | |
3.2. Knowledge of PA-Related Injuries | Participants’ average correct answer score was 10.31 ± 3.68, with 10.57 ± 3.97 for boys and 10.03 ± 3.34 for girls. The analysis of the individual values shows that 33.3% of respondents had a low competence level (score of 1 to 8 points), 61.7% had an intermediate competence level (score of 9 to 16 points), and only 5%... | PMC10001543 | ||
3.3. Sedentary Behaviors | The mean SB score for participants was 2.716 ± 0.61, with 2.79 ± 0.596 for boys and 2.64 ± 0.67 for girls ( | PMC10001543 | ||
3.4. Weekly Physical Activity | The average PA score of the participants was 2.45 ± 0.86 (boys = 2.32 ± 0.9; girls = 2.58 ± 0.8) indicating that our participants ranged from inactive to moderately active. The | PMC10001543 | ||
3.5. Regressions | fits | REGRESSION | Logistic regression was performed to determine the effects of gender, age, BMI, fat mass, lean mass, knowledge of PA-related injuries, SB, and level of PA on the likelihood of having PA-related injuries in general and the likelihood that the injury will require emergency medical attention. The logistic regression model... | PMC10001543 |
4. Discussion | concussions, fractures, injuries, weight loss, sports-related injuries, bruises, upper extremity injury | MINOR, COMPLICATIONS, BROWN | The purpose of this study was two-fold: (1) to assess the frequency of PA-related injuries among Saudi students aged 13–18 to determine the location of the injury in the body area, the types of injuries, and whether or not the injury required urgent medical attention, and (2) to investigate the association of these fac... | PMC10001543 |
5. Conclusions | fractures, injuries, bruises | Findings revealed that boys were 3.52 times more likely to have PA-related injuries than girls. More specific knowledge was associated with a lower likelihood of sustaining a PA-related injury. In contrast, increased SB was associated with a greater likelihood of sustaining a PA-related injury. Bruises and strains were... | PMC10001543 | |
Author Contributions | Methodology, M.A.S., A.A.A. and M.S.A.; validation, M.A.S., A.A.A. and M.S.A.; formal analysis, M.A.S., A.A.A. and M.S.A.; investigation, M.A.S. and A.A.A.; data curation, M.A.S., A.A.A. and M.S.A.; writing—original draft preparation, M.A.S. and A.A.A.; writing—review and editing, M.A.S.; supervision, M.S.A.; project a... | PMC10001543 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Deanship of Scientific Research, King Faisal University (Ref. No. KFU-REC-2021-OCT-EA00019). | PMC10001543 | ||
Informed Consent Statement | Informed consent was obtained from all participants aged 16 or older or parents younger than 16 involved in the study. | PMC10001543 | ||
Data Availability Statement | Data can be provided on request from the corresponding authors. | PMC10001543 | ||
Conflicts of Interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10001543 | ||
References | Sedentary behaviors, injuries, sedentary behaviors | REGRESSION | Correct answer score among Saudi adolescents aged 13–18, who suffered injuries in the last year, stratified by the number of injuries (Sedentary behaviors score among Saudi adolescents aged 13–18, who suffered injuries in the last year, stratified by the number of injuries (Physical activity score among Saudi adolescen... | PMC10001543 |
Purpose | IRON DEFICIENCY | To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14–21 weeks pregnant with persistent iron deficiency (ferritin < 30 µg/L). | PMC10435604 | |
Methods | fatigue | ADVERSE EVENTS, IRON DEFICIENCY | In a single-centre, open-label, randomised controlled trial at a Danish hospital, women with persistent iron deficiency after routine oral iron treatment were allocated to receive 1000 mg IV iron (single-dose) or 100 mg elemental oral iron daily. Outcomes were assessed during an 18-week follow-up period. The primary en... | PMC10435604 |
Results | From July 2017 to February 2020, 100 women were randomised to IV iron and 101 to oral iron. Throughout follow-up, 91% of women were non-anaemic in the IV iron group compared with 73% in the oral iron group (18% difference [95% confidence interval 0.10–0.25]; | PMC10435604 | ||
Conclusion | anaemia, fatigue | ANAEMIA, IRON DEFICIENCY | IV iron was superior in preventing anaemia compared with oral iron in pregnant women with persistent iron deficiency; biochemical superiority was accompanied by improved fatigue and QoL. | PMC10435604 |
Clinical trial registration | MAY | European Clinical Trials Database: EudraCT no.: 2017-000776-29 (3 May 2017); ClinicalTrials.gov: NCT03188445 (13 June 2017).The trial protocol has been published: | PMC10435604 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00404-022-06768-x. | PMC10435604 | ||
Keywords | PMC10435604 | |||
What does this study add to the clinical work | PMC10435604 | |||
Introduction | Worldwide, about 38% of pregnant women are anaemic (haemoglobin [Hb] < 11.0 g/dL) [During pregnancy, iron requirements increase due to placental growth, foetal development and enhanced erythropoiesis [Oral iron is frequently used in the routine treatment of ID and IDA in pregnant women. It is inexpensive, but often poo... | PMC10435604 | ||
Methods | PMC10435604 | |||
Study design, setting and population | anaemia, hypersensitivity, infections | ANAEMIA, HYPERSENSITIVITY, INFECTIONS, MULTIPLE ALLERGIES | A single-centre, open-label, randomised, comparative trial was conducted between July 2017 and February 2020 at the Department of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Denmark. The department employed routine screening for ID and anaemia in the first trimester by measuring Hb and ferritin... | PMC10435604 |
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