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

BMJ 1999; 318 doi: (Published 27 February 1999) Cite this as: BMJ 1999;318:570
  1. Keith P West Jr, professor (kwest{at},
  2. Joanne Katz, professora,
  3. Subarna K Khatry, project directorb,
  4. Steven C LeClerq, esearch associatea,
  5. Elizabeth K Pradhan, research associatea,
  6. Sharada R Shrestha, deputy project directorb,
  7. Paul B Connor, data systems coordinatora,
  8. Sanu M Dali, project obstetrician- gynaecologistb,
  9. Parul Christian, assistant scientist,a,
  10. Ram P Pokhrel, chairmanc,
  11. Alfred Sommer, dean on behalf of the NNIPS-2 Study Group.a
  1. aohns Hopkins School of Hygiene and Public Health, Division of Human Nutrition, Room 2041, 615 N Wolfe Street, Baltimore, MD 21205, USA
  2. bNepal Nutrition Intervention Project-Sarlahi (NNIPS), Nepal Netra Jyoti Sangh, Nepal Eye Hospital Complex, PO Box 335, Tripureswor,Kathmandu, Nepal
  3. c Nepal Netra Jyoti Sangh, Nepal Eye Hospital Complex, PO Box 335, Tripureswor, Kathmandu
  1. Correspondence to: Professor West
  • Accepted 19 January 1999


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.


    • Accepted 19 January 1999
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