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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN28836000 |
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Date of registration:
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27/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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01/01/1995 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN28836000 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind single-centre placebo-controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ann
Prentice |
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Address:
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MRC Human Nutrition Research
Elsie Widdowson Laboratory
Fulbourn Road
CB1 9NL
Cambridge
United Kingdom |
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Telephone:
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+44 (0)122 342 6356 |
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Email:
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ann.prentice@mrc-hnr.cam.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoporosis
Musculoskeletal Diseases
Osteoporosis in diseases classified elsewhere
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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