The Bakary Dibba Study (BDS): Effect of calcium supplementation on growth and bone mineral accretion in Gambian children accustomed to a low calcium diet
| ISRCTN | ISRCTN28836000 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28836000 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/08/2011
- Registration date
- 27/09/2011
- Last edited
- 10/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rural Gambian children have poor growth, delayed puberty, a low bone mineral content, and a very low calcium intake. In this study we are investigating the short and long term effects of calcium supplementation.
Who can participate?
160 children (80 boys, 80 girls) aged 8-12 years old, living in the village of Keneba, in the West Kiang district of The Gambia.
What does the study involve?
Participants are randomly allocated to receive either calcium supplements or matched placebo (dummy) tablets five days a week for a year. We will collect blood and urine samples and measure dietary intake, bone minerals, growth, weight and height and body composition.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The Elsie Widdowson Laboratory (UK).
When is the study starting and how long is it expected to run for?
January 1995 to December 2012.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Dr Ann Prentice
ann.prentice@mrc-hnr.cam.ac.uk
Contact information
Scientific
MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
| Phone | +44 (0)122 342 6356 |
|---|---|
| ann.prentice@mrc-hnr.cam.ac.uk |
Study information
| Study design | Randomised double-blind single-centre placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Short and long term effects of a randomised placebo-controlled calcium supplementation study in Gambian children aged 8-12 years accustomed to a low calcium diet |
| Study acronym | BDS |
| Study objectives | An increase in calcium intake by pre-pubertal children accustomed to a low calcium diet will increase growth and bone moneral accretion |
| Ethics approval(s) | The study was approved by the joint MRC / Gambian Government ethics committee in 1994, ref no SCC 605 |
| Health condition(s) or problem(s) studied | Osteoporosis |
| Intervention | Participants were stratified by sex and randomly assigned to receive a calcium supplement or placebo. The randomisation procedure was conducted by a member of staff in Cambridge UK who was not involved in the data collection. The participants and the field and laboratory staff have remained unaware of the assignments throughout the study. Children were selected in descending age order until the target numbers were achieved. Four children started the study each week to allow recruitment to be spread over a calendar year. Assignment to group was by a randomised permuted block of four to ensure that an equal number of participants was allocated to the calcium and placebo groups each week, to minimise the potential for seasonal confounding. The calcium supplement consisted of two chewable calcium carbonate tablets (Calcichew®; Shire Pharmaceuticals Ltd, Andover, UK and Nycomed Pharma AS, Oslo) containing 500 mg elemental calcium/tablet. The placebo consisted of similar tablets, produced by the manufacturer of the calcium tablets. Each participant received either the calcium supplement or the placebo for 5 days each week for 12 months, starting the week after baseline measurements were taken. The tablets were dispensed to the participants at a centrally located building in the village and were consumed in the early evenings under strict supervision. Follow-up measurements were made 12 and 24 months after the withdrawal of the supplement, and continue to be made regularly throughout late childhood, adolescence and early adulthood. For girls who have started a family, measurements are made during and after lactation. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Bone mineral status measures [initially forearm single photon absorptiometry (SPA), then whole-body and regional dual energy X-ray absorptiometry (DXA)] at 0, 12, 24, 36 months and regular intervals to adulthood 2. Anthropometry (height, weight, mid upper arm circumference, triceps skinfold) at 0, 12, 24, 36 months and regular intervals to adulthood |
| Secondary outcome measures | 1. Biochemical markers of calcium and bone metabolism measured in blood and urine at 0, 12, 24, 36 months and regular intervals to adulthood 2. Body composition measures (whole-body DXA) from 36 months to adulthood 3. Radial and tibial bone and muscle measures by peripheral quantitative computed tomography (pQCT) in early aldulthood |
| Overall study start date | 01/01/1995 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 80 boys and 80 girls |
| Key inclusion criteria | 1. Children aged 8-12 years old living in the rural village of Keneba, West Kiang, The Gambia. 2. Healthy, with no history of any medical condition known to affect calcium or bone metabolism 3. No recent fracture 4. Non-consumer of alcohol, antacids, calcium or other nutritional supplements 5. Non-smokers 6. Girls not on contraceptive pills |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- England
- Gambia
- United Kingdom
Study participating centre
CB1 9NL
United Kingdom
Sponsor information
Research council
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
"ROR" |
https://ror.org/050pqs331 |
|---|
Funders
Funder type
Research council
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 | 01/02/2000 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No | |
| Results article | results | 01/09/2014 | Yes | No |
