Contact information
Type
Scientific
Primary contact
Dr Ann Prentice
ORCID ID
Contact details
MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
ann.prentice@mrc-hnr.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Calcium intakes of pregnant women in rural areas of The Gambia are considerably below recommended levels. There is evidence to suggest that low calcium intakes during pregnancy may be associated with an increased incidence of pregnancy-induced hypertension, reduced maternal bone mineral content, low breast-milk calcium concentrations post-partum, and sub-optimal bone development and growth of the child. The aim of this study is to determine whether pregnant Gambian women would benefit from an increase in calcium intake.
Ethics approval
Ethics approval received from the Medical Research Council (MRC)/Gambian Government Joint Ethics Committee (ref: SCC/EC 585/559).
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Calcium deficiency in pregnancy
Intervention
1500 mg Calcium (Ca) orally per day or placebo until delivery.
Intervention type
Drug
Phase
Not Specified
Drug names
Calcium
Primary outcome measures
1. Maternal blood pressure at 36 - 38 weeks gestation
2. Breast-milk calcium concentration during laction
3. Post-partum bone mineral content of mother and baby
Secondary outcome measures
1. Infant growth and development:
1.1. Weight, measured within 24 hours of birth and at 2, 13 and 52 weeks
1.2. Crown-heel length, measured within 5 days from birth and at 2, 13 and 52 weeks
1.3. Head circumference measured within 5 days from birth and at 2, 13 and 52 weeks
2. Infant blood pressure and growth, measured every two years from age 3
3. Maternal post-partum blood pressure, measured at 2, 13 and 52 weeks post-partum
Overall trial start date
01/01/1995
Overall trial end date
31/12/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Consenting pregnant women at booking.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
No specific exclusion criteria at booking.
Recruitment start date
01/01/1995
Recruitment end date
31/12/2000
Locations
Countries of recruitment
Gambia
Trial participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
WC1E 7HT
United Kingdom
corporate@headoffice.mrc.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Results - basic reporting
Publication summary
1. 2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16522914
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20554790
3. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21677054
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24004887
5. 2013 follow-up study results in: http://www.ncbi.nlm.nih.gov/pubmed/23902782
Publication citations
-
Results
Jarjou LM, Laskey MA, Sawo Y, Goldberg GR, Cole TJ, Prentice A, Effect of calcium supplementation in pregnancy on maternal bone outcomes in women with a low calcium intake., Am. J. Clin. Nutr., 2010, 92, 2, 450-457, doi: 10.3945/ajcn.2010.29217.
-
Results
Hawkesworth S, Walker CG, Sawo Y, Fulford AJ, Jarjou LM, Goldberg GR, Prentice A, Prentice AM, Moore SE, Nutritional supplementation during pregnancy and offspring cardiovascular disease risk in The Gambia., Am. J. Clin. Nutr., 2011, 94, 6 Suppl, 1853S-1860S, doi: 10.3945/ajcn.110.000877.
-
Results
Goldberg GR, Jarjou LM, Cole TJ, Prentice A, Randomized, placebo-controlled, calcium supplementation trial in pregnant Gambian women accustomed to a low calcium intake: effects on maternal blood pressure and infant growth., Am. J. Clin. Nutr., 2013, 98, 4, 972-982, doi: 10.3945/ajcn.113.059923.
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Jarjou LM, Prentice A, Sawo Y, Laskey MA, Bennett J, Goldberg GR, Cole TJ, Randomized, placebo-controlled, calcium supplementation study in pregnant Gambian women: effects on breast-milk calcium concentrations and infant birth weight, growth, and bone mineral accretion in the first year of life., Am. J. Clin. Nutr., 2006, 83, 3, 657-666.
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Jarjou LM, Sawo Y, Goldberg GR, Laskey MA, Cole TJ, Prentice A, Unexpected long-term effects of calcium supplementation in pregnancy on maternal bone outcomes in women with a low calcium intake: a follow-up study., Am. J. Clin. Nutr., 2013, 98, 3, 723-730, doi: 10.3945/ajcn.113.061630.