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The Bakary Dibba Study (BDS): Effect of calcium supplementation on growth and bone mineral accretion in Gambian children accustomed to a low calcium diet

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28836000
Enrollment
160
Registered
2011-09-27
Start date
1995-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Musculoskeletal Diseases Osteoporosis in diseases classified elsewhere

Interventions

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 involve
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 ta

Sponsors

MRC Human Nutrition Research (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026