Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information



Primary contact

Prof Andrew Prentice


Contact details

MRC International Nutrition Group
Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial


Study hypothesis

Antenatal high-energy supplementation improves birth weight and infant survival in rural Gambia

Ethics approval

Ethical approval given by the joint Gambia Government / MRC Unit The Gambia Ethics Committee.

Study design

5 year cluster randomized trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not provided at time of registration - N/A as study ended in 1994.


Pregnancy and lactation


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.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Birth weight
2. Neonatal and postneonatal mortality

Secondary outcome measures

1. Prevalence of low birth weight (< 2500g)
2. Head circumference
3. Birth length
4. Gestational age
5. Prevalence of stillbirths

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Pregnant, with < 20 weeks gestation
2. Resident in West Kiang region of The Gambia

Participant type


Age group




Target number of participants


Participant exclusion criteria

Twin pregnancies

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

MRC International Nutrition Group
United Kingdom

Sponsor information


Medical Research Council (MRC) (UK) - International Nutrition Group (UK)

Sponsor details

Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
United Kingdom

Sponsor type

Research council



Funder type

Research council

Funder name

Medical Research Council, Overseas Development Administration and Nestle Foundation.

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1997 results in:
2014 results in:

Publication citations

  1. Results

    Ceesay SM, Prentice AM, Cole TJ, Foord F, Weaver LT, Poskitt EM, Whitehead RG, Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial ., BMJ, 1997, 315, 7111, 786-790.

  2. Results

    Alderman H, Hawkesworth S, Lundberg M, Tasneem A, Mark H, Moore SE, Supplemental feeding during pregnancy compared with maternal supplementation during lactation does not affect schooling and cognitive development through late adolescence., Am. J. Clin. Nutr., 2014, 99, 1, 122-129, doi: 10.3945/ajcn.113.063404.

Additional files

Editorial Notes