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Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia
ISRCTN ISRCTN72582014
DOI 10.1186/ISRCTN72582014
ClinicalTrials.gov identifier
EudraCT number
Public title Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia
Scientific title Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis Antenatal high-energy supplementation improves birth weight and infant survival in rural Gambia
Lay summary Background and study aims
Low birth weight is a major contributor to mortality during infancy. This study was designed to see if supplementing rural African women with a high energy and protein dietary supplement from mid-pregnancy to delivery would improve both low birth weight and infant survival.

Who can participate?
The study enrolled consenting pregnant women living in the West Kiang region of The Gambia.

What does the study involve?
This study is completed, having run between January 1989 and October 1994. Women in 28 villages in rural Gambia were randomly allocated to one of two groups: to receive a biscuit supplement from either mid-pregnancy to delivery (intervention group) or from delivery for 20 weeks (control group). Birth weight, length and head circumference and survival of the infants up to 12 months of age was assessed.

What are the possible benefits and risks of participating?
These are the findings of the study: Supplementation during pregnancy increased birth weight by 136g. The supplement had greatest impact when given during the nutritionally poor 'hungry season (+201g). In addition, the supplement reduced the prevalence of babies born with a low birth weight (<2500g). Supplementation also reduced the risk of stillbirths and deaths during the first week of life. This study showed that giving a high energy and protein supplement to women during pregnancy in rural Gambia can improve birth weight and early neonatal survival.

Where is the study run from?
The study was run from the Medical Research Council (UK) Keneba field station, in Keneba, The Gambia.

When is the study starting and how long is it expected to run for?
The study started in 1989 and field work was completed in 1994. It was published in 1997.

Who is funding the study?
The study was funded by the Medical Research Council (UK), the Overseas Development Administration (UK) and the Nestle Foundation (Switzerland).

Who is the main contact?
Professor Andrew Prentice
Andrew.Prentice@lshtm.ac.uk
Ethics approval Ethical approval given by the joint Gambia Government / MRC Unit The Gambia Ethics Committee.
Study design 5 year cluster randomized trial
Countries of recruitment Gambia
Disease/condition/study domain Pregnancy and lactation
Participants - inclusion criteria 1. Pregnant, with < 20 weeks gestation
2. Resident in West Kiang region of The Gambia
Participants - exclusion criteria Twin pregnancies
Anticipated start date 01/01/1989
Anticipated end date 31/10/1994
Status of trial Completed
Patient information material Not provided at time of registration - N/A as study ended in 1994.
Target number of participants 2047
Interventions 5 year cluster randomized trial of pregnant women in 28 villages in rural Gambia to daily supplementation with high energy biscuits for 20 weeks pre-delivery (intervention) or post-delivery (control).

Two biscuits daily, made locally from roasted groundnuts, rice flour, sugar and groundnut oil and providing a maximum daily intake of 4250 kJ energy, 22 g protein, 56 g fat, 47 mg calcium and 1.8mg iron. Biscuits were distributed to birth attendants in each village, who issued them to participating women and observed consumption.
Primary outcome measure(s) 1. Birth weight
2. Neonatal and postneonatal mortality
Secondary outcome measure(s) 1. Prevalence of low birth weight (< 2500g)
2. Head circumference
3. Birth length
4. Gestational age
5. Prevalence of stillbirths
Sources of funding Medical Research Council, Overseas Development Administration and Nestle Foundation.
Trial website
Publications 1997 results in: http://www.ncbi.nlm.nih.gov/pubmed/9345173
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24132979
Contact name Prof  Andrew  Prentice
  Address MRC International Nutrition Group
Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email andrew.prentice@lshtm.ac.uk
Sponsor Medical Research Council (MRC) (UK) - International Nutrition Group (UK)
  Address Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email andrew.prentice@lshtm.ac.uk
  Sponsor website: http://www.ing.mrc.ac.uk
Date applied 05/02/2013
Last edited 26/02/2014
Date ISRCTN assigned 27/03/2013
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