Double blind, cluster randomised trial of low dose supplementation with vitamin A or βcarotene on mortality related to pregnancy in Nepal

Keith P. West, Joanne Katz, Steven C. Leclerq, Elizabeth K. Pradhan, Paul B. Connor, Parul Christian, Alfred Sommer, Subarna K. Khatry, Sharada R. Shrestha, Sanu M. Dali, Ram P. Pokhrel

Research output: Contribution to journalArticlepeer-review

361 Scopus citations

Abstract

Objective: To assess the impact on mortality related to pregnancy of supplementing women of reproductive age each week with a recommended dietary allowance of vitamin A, either preformed or as βcarotene. Design: Double blind, cluster randomised, placebo controlled field trial. Setting: Rural southeast central plains of Nepal (Sarlahi district). Subjects: 44646 married women, of whom 20119 became pregnant 22189 times. Intervention: 270 wards randomised to 3groups of 90each for women to receive weekly a single oral supplement of placebo, vitamin A (7000¼g retinol equivalents) or βcarotene (42mg, or 7000¼g retinol equivalents) for over 31/2 years. Main outcome measures: All cause mortality in women during pregnancy up to 12weekspost partum (pregnancy related mortality) and mortality during pregnancy to 6weeks postpartum, excluding deaths apparently related to injury (maternal mortality). Results: Mortality related to pregnancy in the placebo, vitamin A, and βcarotene groups was 704,426,and 361deaths per 100000 pregnancies, yielding relative risks (95% confidence intervals) of 0.60(0.37to 0.97) and 0.51(0.30to 0.86). This represented reductions of 40% (P<0.04)and 49% (P<0.01) among those who received vitamin A and βcarotene. Combined, vitaminA or βcarotene lowered mortality by 44% (0.56(0.37to 0.84), P<0.005) and reduced the maternal mortality ratio from 645to 385deaths per 100000 live births, or by 40% (P<0.02). Differences in cause of death could not be reliably distinguished between supplemented and placebo groups. Conclusion: Supplementation of women with either vitamin A or βcarotene at recommended dietary amounts during childbearing years can lower mortality related to pregnancy in rural, undernourished populations of south Asia.

Original languageEnglish (US)
Pages (from-to)570-575
Number of pages6
JournalBMJ
Volume318
Issue number7183
DOIs
StatePublished - Feb 27 1999

ASJC Scopus subject areas

  • General Medicine

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