Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group
- PMID: 10037634
- PMCID: PMC27760
- DOI: 10.1136/bmj.318.7183.570
Double blind, cluster randomised trial of low dose supplementation with vitamin A or beta carotene on mortality related to pregnancy in Nepal. The NNIPS-2 Study Group
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 beta carotene.
Design: Double blind, cluster randomised, placebo controlled field trial.
Setting: Rural southeast central plains of Nepal (Sarlahi district).
Subjects: 44 646 married women, of whom 20 119 became pregnant 22 189 times.
Intervention: 270 wards randomised to 3 groups of 90 each for women to receive weekly a single oral supplement of placebo, vitamin A (7000 micrograms retinol equivalents) or beta carotene (42 mg, or 7000 micrograms retinol equivalents) for over 31/2 years.
Main outcome measures: All cause mortality in women during pregnancy up to 12 weeks post partum (pregnancy related mortality) and mortality during pregnancy to 6 weeks postpartum, excluding deaths apparently related to injury (maternal mortality).
Results: Mortality related to pregnancy in the placebo, vitamin A, and beta carotene groups was 704, 426, and 361 deaths per 100 000 pregnancies, yielding relative risks (95% confidence intervals) of 0. 60 (0.37 to 0.97) and 0.51 (0.30 to 0.86). This represented reductions of 40% (P<0.04) and 49% (P<0.01) among those who received vitamin A and beta carotene. Combined, vitamin A or beta carotene lowered mortality by 44% (0.56 (0.37 to 0.84), P<0.005) and reduced the maternal mortality ratio from 645 to 385 deaths per 100 000 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 beta carotene at recommended dietary amounts during childbearing years can lower mortality related to pregnancy in rural, undernourished populations of south Asia.
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Comment in
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Effect of vitamin A and beta carotene supplementation on women's health.BMJ. 1999 Feb 27;318(7183):551-2. doi: 10.1136/bmj.318.7183.551. BMJ. 1999. PMID: 10037611 Free PMC article.
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Effect of supplementation with vitamin A or beta carotene on mortality related to pregnancy. Pooling of groups may not be appropriate.BMJ. 1999 Oct 30;319(7218):1201-2; author reply 1203. BMJ. 1999. PMID: 10541530 Free PMC article. No abstract available.
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Effect of supplementation with vitamin A or beta carotene on mortality related to pregnancy. No magic pills exist for reducing mortality related to pregnancy.BMJ. 1999 Oct 30;319(7218):1202; author reply 1203. BMJ. 1999. PMID: 10610158 No abstract available.
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Effect of supplementation with vitamin A or beta carotene on mortality related to pregnancy. Slight modifications in definitions could alter interpretation of results.BMJ. 1999 Oct 30;319(7218):1202-3. BMJ. 1999. PMID: 10610159 No abstract available.
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