title: Effect of vitamin A supplementation in women of reproductive age on maternal survival in Ghana (ObaapaVitA): a cluster-randomised, placebo-controlled trial.
abstract: BACKGROUND
  A previous trial in Nepal showed that supplementation with vitamin A or its precursor (betacarotene) in women of reproductive age reduced pregnancy-related mortality by 44% (95% CI 16-63). We assessed the effect of vitamin A supplementation in women in Ghana.
  
  
  METHODS
  ObaapaVitA was a cluster-randomised, double-blind, placebo-controlled trial undertaken in seven districts in Brong Ahafo Region in Ghana. The trial area was divided into 1086 small geographical clusters of compounds with fieldwork areas consisting of four contiguous clusters. All women of reproductive age (15-45 years) who gave informed consent and who planned to remain in the area for at least 3 months were recruited. Participants were randomly assigned by cluster of residence to receive a vitamin A supplement (25 000 IU retinol equivalents) or placebo capsule orally once every week. Randomisation was blocked and based on an independent, computer-generated list of numbers, with two clusters in each fieldwork area allocated to vitamin A supplementation and two to placebo. Capsules were distributed during home visits undertaken every 4 weeks, when data were gathered on pregnancies, births, and deaths. Primary outcomes were pregnancy-related mortality and all-cause female mortality. Cause of death was established by verbal post mortems. Analysis was by intention to treat (ITT) with random-effects regression to account for the cluster-randomised design. Adverse events were synonymous with the trial outcomes. This trial is registered with ClinicalTrials.gov, number NCT00211341.
  
  
  RESULTS
  544 clusters (104 484 women) were randomly assigned to vitamin A supplementation and 542 clusters (103 297 women) were assigned to placebo. The main reason for participant drop out was migration out of the study area. In the ITT analysis, there were 39 601 pregnancies and 138 pregnancy-related deaths in the vitamin A supplementation group (348 deaths per 100 000 pregnancies) compared with 39 234 pregnancies and 148 pregnancy-related deaths in the placebo group (377 per 100 000 pregnancies); adjusted odds ratio 0.92, 95% CI 0.73-1.17; p=0.51. 1326 women died in 292 560 woman-years in the vitamin A supplementation group (453 deaths per 100 000 years) compared with 1298 deaths in 289 310 woman-years in the placebo group (449 per 100 000 years); adjusted rate ratio 1.01, 0.93-1.09; p=0.85.
  
  
  CONCLUSIONS
  The body of evidence, although limited, does not support inclusion of vitamin A supplementation for women in either safe motherhood or child survival strategies.
  
  
  BACKGROUND
  UK Department for International Development, and USAID.
authors.affiliation: Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. betty.kirkwood@lshtm.ac.uk
authors.forename: Betty R
authors.initials: BR
authors.lastname: Kirkwood
authors.forename: Lisa
authors.initials: L
authors.lastname: Hurt
authors.forename: Seeba
authors.initials: S
authors.lastname: Amenga-Etego
authors.forename: Charlotte
authors.initials: C
authors.lastname: Tawiah
authors.forename: Charles
authors.initials: C
authors.lastname: Zandoh
authors.forename: Samuel
authors.initials: S
authors.lastname: Danso
authors.forename: Chris
authors.initials: C
authors.lastname: Hurt
authors.forename: Karen
authors.initials: K
authors.lastname: Edmond
authors.forename: Zelee
authors.initials: Z
authors.lastname: Hill
authors.forename: Guus
authors.initials: G
authors.lastname: Ten Asbroek
authors.forename: Justin
authors.initials: J
authors.lastname: Fenty
authors.forename: Seth
authors.initials: S
authors.lastname: Owusu-Agyei
authors.forename: Oona
authors.initials: O
authors.lastname: Campbell
authors.forename: Paul
authors.initials: P
authors.lastname: Arthur
mesh_terms: D000293:Adolescent; D000328:Adult; D002423:Cause of Death; D019587:Dietary Supplements; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005869:Ghana / Q000453:epidemiology; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011248:Pregnancy Complications / Q000401:mortality* / Q000517:prevention & control; D014801:Vitamin A / Q000008:administration & dosage* / Q000097:blood; D055815:Young Adult; D019207:beta Carotene / Q000008:administration & dosage
chemical_list: D019207:beta Carotene; D014801:Vitamin A