Condition category
Pregnancy and Childbirth
Date applied
11/09/2007
Date assigned
06/11/2007
Last edited
28/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes