title: Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial.
abstract: 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.
  
  
  METHODS
  A 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.
  
  
  METHODS
  Rural Rufiji District, Tanzania.
  
  
  METHODS
  Non-pregnant women and adolescent girls aged 15-29 years (n = 802).
  
  
  RESULTS
  The 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).
  
  
  CONCLUSIONS
  Daily 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01183572.
authors.affiliation: Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Nilupa S
authors.initials: NS
authors.lastname: Gunaratna
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Honorati
authors.initials: H
authors.lastname: Masanja
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Sigilbert
authors.initials: S
authors.lastname: Mrema
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Francis
authors.initials: F
authors.lastname: Levira
authors.affiliation: Departments of Epidemiology, Biostatistics, and Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Donna
authors.initials: D
authors.lastname: Spiegelman
authors.affiliation: Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Ellen
authors.initials: E
authors.lastname: Hertzmark
authors.affiliation: Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Naomi
authors.initials: N
authors.lastname: Saronga
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Kahema
authors.initials: K
authors.lastname: Irema
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Mary
authors.initials: M
authors.lastname: Shuma
authors.affiliation: Ifakara Health Institute, Dar es Salaam, Tanzania.
authors.forename: Ester
authors.initials: E
authors.lastname: Elisaria
authors.affiliation: Departments of Global Health and Population, Epidemiology, and Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
authors.forename: Wafaie
authors.initials: W
authors.lastname: Fawzi
mesh_terms: D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage; D006801:Humans; D007501:Iron / Q000008:administration & dosage*; D009752:Nutritional Status; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control; D011256:Pregnancy Outcome; D012424:Rural Population; D013636:Tanzania; D014815:Vitamins / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D014815:Vitamins; D005492:Folic Acid; D007501:Iron