Dataset Information

Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial.

ABSTRACT: Anemia is common in pregnancy and increases the risk of adverse outcomes. Iron deficiency is a leading cause of anemia in sub-Saharan Africa, and iron supplementation is the standard of care during pregnancy; however, recent trials among children have raised concerns regarding the safety of iron supplementation in malaria-endemic regions. There is limited evidence on the safety of iron supplementation during pregnancy in these areas.To evaluate the safety and efficacy of iron supplementation during pregnancy in a malaria-endemic region.We conducted a randomized, double-blind, placebo-controlled clinical trial among pregnant women presenting for antenatal care in Dar es Salaam, Tanzania, from September 28, 2010, through October 4, 2012. Iron-replete, nonanemic women were eligible if they were uninfected with human immunodeficiency virus, primigravidae or secundigravidae, and at or before 27 weeks of gestation. Screening of 21,316 women continued until the target enrollment of 1500 was reached. Analyses followed the intent-to-treat principle and included all randomized participants.Participants were randomized to receive 60 mg of iron or placebo, returning every 4 weeks for standard prenatal care, including malaria screening, prophylaxis with the combination of sulfadoxine and pyrimethamine, and treatment, as needed.The primary outcomes were placental malaria, maternal hemoglobin level at delivery, and birth weight.Among 1500 study participants (750 randomized for each group), 731 in iron group and 738 in placebo group had known birth outcomes and 493 in iron group and 510 in placebo group had placental samples included in the analysis. Maternal characteristics were similar at baseline in the iron and placebo groups, and 1354 (91.7%) used malaria control measures. The risk of placental malaria was not increased by maternal iron supplementation (relative risk [RR], 1.03; 95% CI, 0.65-1.65), and iron supplementation did not significantly affect birth weight (3155 vs 3137 g, P =?.89). Compared with placebo, iron supplementation significantly improved the mean increase from baseline to delivery for hemoglobin (0.1 vs -0.7 g/dL, P

SUBMITTER: Etheredge AJ

PROVIDER: S-EPMC4904713 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial.

Etheredge Analee J AJ Premji Zul Z Gunaratna Nilupa S NS Abioye Ajibola Ibraheem AI Aboud Said S Duggan Christopher C Mongi Robert R Meloney Laura L Spiegelman Donna D Roberts Drucilla D Hamer Davidson H DH Fawzi Wafaie W WW

JAMA pediatrics 20151001 10

<h4>Importance</h4>Anemia is common in pregnancy and increases the risk of adverse outcomes. Iron deficiency is a leading cause of anemia in sub-Saharan Africa, and iron supplementation is the standard of care during pregnancy; however, recent trials among children have raised concerns regarding the safety of iron supplementation in malaria-endemic regions. There is limited evidence on the safety of iron supplementation during pregnancy in these areas.<h4>Objective</h4>To evaluate the safety and ...[more]

PMID: 26280534

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Project description:CONTEXT:Supplementing iron-deficient nonanemic (IDNA) athletes with iron to improve performance is a trend in endurance sports. OBJECTIVES:To investigate the benefits of iron on performance, identify a ferritin level cutoff in IDNA athletes, and determine which iron supplementation regimens are most effective. DATA SOURCES:A search of the PubMed, CINAHL, Embase, ERIC, and Cochrane databases was performed in 2014 including all articles. Citations of pertinent review articles were also searched. In 2017, the search was repeated. STUDY SELECTION:Inclusion criteria comprised studies of level 1 to 3 evidence, written in the English language, that researched iron supplementation in nonanemic athletes and reported performance outcomes. STUDY DESIGN:Systematic review. LEVEL OF EVIDENCE:Level 3. DATA EXTRACTION:The search terms used included athletic performance, resistance training, athletes, physical endurance, iron, iron deficiency, supplement, non-anemic, low ferritin, ferritin, ferritin blood level, athletes, and sports. RESULTS:A total of 1884 studies were identified through the initial database search, and 13 were identified through searching references of relevant review articles. A subsequent database search identified 46 studies. Following exclusions, 12 studies with a total of 283 participants were included. Supplementing IDNA athletes with iron improved performance in 6 studies (146 participants) and did not improve performance in the other 6 studies (137 participants). In the 6 studies that showed improved performance with iron supplementation, all used a ferritin level cutoff of ?20 ?g/L for treatment. Additionally, all studies that showed improved performance used oral iron as a supplement. CONCLUSION:The evidence is equivocal as to whether iron supplementation in IDNA athletes improves athletic performance. Supplementing athletes with ferritin levels <20 ?g/L may be more beneficial than supplementing athletes with higher baseline ferritin levels.

Project description:Introduction:Pregnant women are at a high risk of anaemia, with iron-folate deficiency being the most common cause of anaemia among pregnant women. Despite the well-known importance of iron and folic acid supplementation (IFAS) during pregnancy, adherence to these supplements is relatively low and associated factors were not well identified in the study area. This study is aimed at investigating adherence to IFAS and associated factors among pregnant women in Kasulu district, north-western Tanzania. Methods:A health facility cross-sectional survey with a mixed-method approach was conducted in Kasulu district from March to April 2019. A structured questionnaire was given to 320 women with children aged 0-6 months to assess factors associated with adherence to IFAS among pregnant women. Data were entered into SPSS version 22.0 for analysis. Binary logistic regression was further employed to determine the factors associated with adherence to IFAS. Focus group discussions were done with 19 pregnant women and 15 mothers of children aged 0-6 months to obtain more clarifications on the factors associated with adherence to IFAS. Furthermore, in-depth interviews were done with six health care providers to explore their perceptions of IFAS. Results:Out of the 320 respondents of the survey, 20.3% (n = 65) adhered to IFAS. Factors associated with adherence to IFAS among pregnant women included time to start ANC (AOR = 3.72, 95% CI: 1.42, 9.79), knowledge of anaemia (AOR = 3.84, 95% CI: 1.335, 10.66), counseling on the importance of the iron-folic acid (AOR = 3.86, 95% CI: 1.42, 10.50), IFAS given during clinical visit (AOR = 15.72, 95% CI: 5.34, 46.31), number of meals consumed (AOR = 3.44, 95% CI: 1.28, 9.21), number of children (AOR = 3.462, 95% CI: 1.035, 11.58), and distance to health facility (AOR = 0.34, 95% CI: 0.131, 0.886). Qualitative findings revealed that delayed first ANC visit, lack of remainder for pregnant women to take IFAS, low awareness about the negative effects of anaemia, low of knowledge of IFAS and management of side effects, negative beliefs about the use of IFAS, and follow-up mechanism were major reasons for poor adherence. Conclusion:Adherence to iron-folic acid supplementation during pregnancy was low. Strengthening systems for creating reminding mechanism, raising community awareness through educational programs to pregnant women and health providers could improve adherence to IFAS.

Project description:ImportanceAlthough blood donation is allowed every 8 weeks in the United States, recovery of hemoglobin to the currently accepted standard (12.5 g/dL) is frequently delayed, and some donors become anemic.ObjectiveTo determine the effect of oral iron supplementation on hemoglobin recovery time (days to recovery of 80% of hemoglobin removed) and recovery of iron stores in iron-depleted ("low ferritin," ≤26 ng/mL) and iron-replete ("higher ferritin," >26 ng/mL) blood donors.Design, setting, and participantsRandomized, nonblinded clinical trial of blood donors stratified by ferritin level, sex, and age conducted in 4 regional blood centers in the United States in 2012. Included were 215 eligible participants aged 18 to 79 years who had not donated whole blood or red blood cells within 4 months.InterventionsOne tablet of ferrous gluconate (37.5 mg of elemental iron) daily or no iron for 24 weeks (168 days) after donating a unit of whole blood (500 mL).Main outcomes and measuresTime to recovery of 80% of the postdonation decrease in hemoglobin and recovery of ferritin level to baseline as a measure of iron stores.ResultsThe mean baseline hemoglobin levels were comparable in the iron and no-iron groups and declined from a mean (SD) of 13.4 (1.1) g/dL to 12.0 (1.2) g/dL after donation in the low-ferritin group and from 14.2 (1.1) g/dL to 12.9 (1.2) g/dL in the higher-ferritin group. Compared with participants who did not receive iron supplementation, those who received iron supplementation had shortened time to 80% hemoglobin recovery in both the low-ferritin (mean, 32 days, interquartile range [IQR], 30-34, vs 158 days, IQR, 126->168) and higher-ferritin groups (31 days, IQR, 29-33, vs 78 days, IQR, 66-95). Median time to recovery to baseline ferritin levels in the low-ferritin group taking iron was 21 days (IQR, 12-84). For participants not taking iron, recovery to baseline was longer than 168 days (IQR, 128->168). Median time to recovery to baseline in the higher-ferritin group taking iron was 107 days (IQR, 75-141), and for participants not taking iron, recovery to baseline was longer than 168 days (IQR, >168->168). Recovery of iron stores in all participants who received supplements took a median of 76 days (IQR, 20-126); for participants not taking iron, median recovery time was longer than 168 days (IQR, 147->168 days; P < .001). Without iron supplements, 67% of participants did not recover iron stores by 168 days.Conclusions and relevanceAmong blood donors with normal hemoglobin levels, low-dose iron supplementation, compared with no supplementation, reduced time to 80% recovery of the postdonation decrease in hemoglobin concentration in donors with low ferritin (≤26 ng/mL) or higher ferritin (>26 ng/mL).Trial registrationclinicaltrials.gov Identifier: NCT01555060.

Project description:ImportanceMaternal smoking during pregnancy adversely affects offspring lung development, with lifelong decreases in pulmonary function and increased asthma risk. In a primate model, vitamin C blocked some of the in-utero effects of nicotine on lung development and offspring pulmonary function.ObjectiveTo determine if newborns of pregnant smokers randomized to receive daily vitamin C would have improved results of pulmonary function tests (PFTs) and decreased wheezing compared with those randomized to placebo.Design, setting, and participantsRandomized, double-blind trial conducted in 3 sites in the Pacific Northwest between March 2007 and January 2011. One hundred fifty-nine newborns of randomized pregnant smokers (76 vitamin C treated and 83 placebo treated) and 76 newborns of pregnant nonsmokers were studied with newborn PFTs. Follow-up assessment including wheezing was assessed through age 1 year, and PFTs were performed at age 1 year.InterventionsPregnant women were randomized to receive vitamin C (500 mg/d) (n = 89) or placebo (n = 90).Main outcomes and measuresThe primary outcome was measurement of newborn pulmonary function (ratio of the time to peak tidal expiratory flow to expiratory time [TPTEF:TE] and passive respiratory compliance per kilogram [Crs/kg]) within 72 hours of age. Secondary outcomes included incidence of wheezing through age 1 year and PFT results at age 1 year. A subgroup of pregnant smokers and nonsmokers had genotyping performed.ResultsNewborns of women randomized to vitamin C (n = 76), compared with those randomized to placebo (n = 83), had improved pulmonary function as measured by TPTEF:TE (0.383 vs 0.345 [adjusted 95% CI for difference, 0.011-0.062]; P = .006) and Crs/kg (1.32 vs 1.20 mL/cm H2O/kg [95% CI, 0.02-0.20]; P = .01). Offspring of women randomized to vitamin C had significantly decreased wheezing through age 1 year (15/70 [21%] vs 31/77 [40%]; relative risk, 0.56 [95% CI, 0.33-0.95]; P = .03). There were no significant differences in the 1-year PFT results between the vitamin C and placebo groups. The effect of maternal smoking on newborn lung function was associated with maternal genotype for the α5 nicotinic receptor (rs16969968) (P < .001 for interaction).Conclusions and relevanceSupplemental vitamin C taken by pregnant smokers improved newborn PFT results and decreased wheezing through 1 year in the offspring. Vitamin C in pregnant smokers may be an inexpensive and simple approach to decrease the effects of smoking in pregnancy on newborn pulmonary function and respiratory morbidities.Trial registrationclinicaltrials.gov Identifier: NCT00632476.

Dataset Information

Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial.

Publications

Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial.

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