Document Detail

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.
MedLine Citation:
PMID:  10037634     Owner:  NLM     Status:  MEDLINE    
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.
K P West; J Katz; S K Khatry; S C LeClerq; E K Pradhan; S R Shrestha; P B Connor; S M Dali; P Christian; R P Pokhrel; A Sommer
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  BMJ (Clinical research ed.)     Volume:  318     ISSN:  0959-8138     ISO Abbreviation:  BMJ     Publication Date:  1999 Feb 
Date Detail:
Created Date:  1999-03-30     Completed Date:  1999-03-30     Revised Date:  2013-04-17    
Medline Journal Info:
Nlm Unique ID:  8900488     Medline TA:  BMJ     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  570-5     Citation Subset:  AIM; IM    
Johns Hopkins School of Hygiene and Public Health, Division of Human Nutrition, Room 2041, 615 N Wolfe Street, Baltimore, MD 21205, USA.
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MeSH Terms
Administration, Oral
Cause of Death
Cluster Analysis
Dietary Supplements
Double-Blind Method
Maternal Mortality
Nepal / epidemiology
Pregnancy Complications / mortality*,  prevention & control
Rural Health / statistics & numerical data
Vitamin A / administration & dosage*
beta Carotene / administration & dosage*
Reg. No./Substance:
11103-57-4/Vitamin A; 7235-40-7/beta Carotene
Comment In:
BMJ. 1999 Oct 30;319(7218):1202; author reply 1203   [PMID:  10610158 ]
BMJ. 1999 Oct 30;319(7218):1201-2; author reply 1203   [PMID:  10541530 ]
BMJ. 1999 Feb 27;318(7183):551-2   [PMID:  10037611 ]
BMJ. 1999 Oct 30;319(7218):1202-3   [PMID:  10610159 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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