Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia

ISRCTN	ISRCTN72582014
DOI	https://doi.org/10.1186/ISRCTN72582014
Secondary identifying numbers	N/A

Submission date: 05/02/2013
Registration date: 27/03/2013
Last edited: 26/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Andrew Prentice
Scientific

MRC International Nutrition Group
Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Email	andrew.prentice@lshtm.ac.uk

Study information

Study design	5 year cluster randomized trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not provided at time of registration - N/A as study ended in 1994.
Scientific title	Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial
Study objectives	Antenatal high-energy supplementation improves birth weight and infant survival in rural Gambia
Ethics approval(s)	Ethical approval given by the joint Gambia Government / MRC Unit The Gambia Ethics Committee.
Health condition(s) or problem(s) studied	Pregnancy and lactation
Intervention	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	Other
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 study start date	01/01/1989
Completion date	31/10/1994

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2047
Key inclusion criteria	1. Pregnant, with < 20 weeks gestation 2. Resident in West Kiang region of The Gambia
Key exclusion criteria	Twin pregnancies
Date of first enrolment	01/01/1989
Date of final enrolment	31/10/1994

Locations

Countries of recruitment

England
Gambia
United Kingdom

Study participating centre

MRC International Nutrition Group

London
WC1E 7HT
United Kingdom

Sponsor information

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

Department of Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Email	andrew.prentice@lshtm.ac.uk
Website	http://www.ing.mrc.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council, Overseas Development Administration and Nestle Foundation.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/09/1997		Yes	No
Results article	results	01/01/2014		Yes	No