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Calcium requirements of pregnant women in The Gambia
ISRCTN ISRCTN96502494
DOI 10.1186/ISRCTN96502494
ClinicalTrials.gov identifier
EudraCT number
Public title Calcium requirements of pregnant women in The Gambia
Scientific title
Acronym N/A
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Gambia
Disease/condition/study domain Calcium deficiency in pregnancy
Participants - inclusion criteria Consenting pregnant women at booking.
Participants - exclusion criteria No specific exclusion criteria at booking.
Anticipated start date 01/01/1995
Anticipated end date 31/12/2000
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 600
Interventions 1500 mg Calcium (Ca) orally per day or placebo until delivery.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 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
Contact name Dr  Ann  Prentice
  Address MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
  City/town Cambridge
  Zip/Postcode CB1 9NL
  Country United Kingdom
  Email ann.prentice@mrc-hnr.cam.ac.uk
Sponsor Medical Research Council (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email corporate@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 11/09/2007
Last edited 28/10/2013
Date ISRCTN assigned 06/11/2007
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