Calcium requirements of pregnant women in The Gambia
| ISRCTN | ISRCTN96502494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96502494 |
- 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
Scientific
MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
| ann.prentice@mrc-hnr.cam.ac.uk |
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Calcium |
| Primary outcome measure | 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 study start date | 01/01/1995 |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- Gambia
- United Kingdom
Study participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
CB1 9NL
United Kingdom
Sponsor information
Medical Research Council (UK)
Government
Government
20 Park Crescent
London
WC1E 7HT
United Kingdom
| corporate@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Government
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 | 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 |
Editorial Notes
11/06/2024: Publication reference added.
