Abstract

ObjectiveWomen’s nutritional status during conception and early pregnancy can influence maternal and infant outcomes. This study examined the efficacy of pre-pregnancy supplementation with iron and multivitamins to reduce the prevalence of anemia during the periconceptional period among rural Tanzanian women and adolescent girls.DesignA double-blind, randomized controlled trial was conducted in which participants were individually randomized to receive daily oral supplements of folic acid alone, folic acid and iron, or folic acid, iron, and vitamins A, B-complex, C, and E at approximately single recommended dietary allowance (RDA) doses for six months.SettingRural Rufiji District, Tanzania.SubjectsNon-pregnant women and adolescent girls aged 15–29 years (n = 802).ResultsThe study arms were comparable in demographic and socioeconomic characteristics, food security, nutritional status, pregnancy history, and compliance with the regimen (p>0.05). In total, 561 participants (70%) completed the study and were included in the intention-to-treat analysis. Hemoglobin levels were not different across treatments (median: 11.1 g/dL, Q1-Q3: 10.0–12.4 g/dL, p = 0.65). However, compared with the folic acid arm (28%), there was a significant reduction in the risk of hypochromic microcytic anemia in the folic acid and iron arm (17%, RR: 0.61, 95% CI: 0.42–0.90, p = 0.01) and the folic acid, iron, and multivitamin arm (19%, RR: 0.66, 95% CI: 0.45–0.96, p = 0.03). Inverse probability of treatment weighting (IPTW) to adjust for potential selection bias due to loss to follow-up did not materially change these results. The effect of the regimens was not modified by frequency of household meat consumption, baseline underweight status, parity, breastfeeding status, or level of compliance (in all cases, p for interaction>0.2).ConclusionsDaily oral supplementation with iron and folic acid among women and adolescents prior to pregnancy reduces risk of anemia. The potential benefits of supplementation on the risk of periconceptional anemia and adverse pregnancy outcomes warrant investigation in larger studies.Trial RegistrationClinicalTrials.gov NCT01183572

Highlights

  • Anemia during pregnancy has been associated with adverse outcomes including maternal and perinatal mortality, pre-term delivery, and low birth weight [1, 2]

  • Compared with the folic acid arm (28%), there was a significant reduction in the risk of hypochromic microcytic anemia in the folic acid and iron arm (17%, relative risk (RR): 0.61, 95% confidence intervals (CI): 0.42–0.90, p = 0.01) and the folic acid, iron, and multivitamin arm (19%, RR: 0.66, 95% CI: 0.45–0.96, p = 0.03)

  • Weights were calculated as the inverse of predicted values from a logistic regression of the following categorical variables on loss to follow-up: infrequent household meat consumption, underweight status at baseline, high parity at baseline, breastfeeding status at baseline, ever reporting side effects during the intervention, ever reporting a feeling of having more energy or strength during the intervention, ever reporting better ability to concentrate during the intervention, ever reporting better ability to work during the intervention, and low compliance

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Summary

Objective

Women’s nutritional status during conception and early pregnancy can influence maternal and infant outcomes. This study examined the efficacy of pre-pregnancy supplementation with iron and multivitamins to reduce the prevalence of anemia during the periconceptional period among rural Tanzanian women and adolescent girls. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Design
Results
Conclusions
Introduction
Ethics statement
Study design and intervention
Discussion
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