Calcium requirements of pregnant women in The Gambia

ISRCTN	ISRCTN96502494
DOI	https://doi.org/10.1186/ISRCTN96502494
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Medical Research Council (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 11/09/2007
Registration date: 06/11/2007
Last edited: 11/06/2024

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

Not provided at time of registration

Contact information

Dr Ann Prentice
Scientific

MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

Email	ann.prentice@mrc-hnr.cam.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Calcium requirements of pregnant women in The Gambia
Study objectives	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(s)	Ethics approval received from the Medical Research Council (MRC)/Gambian Government Joint Ethics Committee (ref: SCC/EC 585/559).
Health condition(s) or problem(s) studied	Calcium deficiency in pregnancy
Intervention	1500 mg Calcium (Ca) orally per day or placebo until delivery.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Calcium
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
Key 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
Completion date	31/12/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key inclusion criteria	Consenting pregnant women at booking.
Key exclusion criteria	No specific exclusion criteria at booking.
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/2000

Locations

Countries of recruitment

United Kingdom
England
Gambia

Study participating centre

MRC Human Nutrition Research

Cambridge
CB1 9NL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/03/2006		Yes	No
Results article	results	01/08/2010		Yes	No
Results article	results	01/12/2011		Yes	No
Results article	follow-up study results	01/09/2013		Yes	No
Results article	results	01/10/2013		Yes	No
Results article	follow-up on blood pressure and growth	18/04/2024	11/06/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/06/2024: Publication reference added.