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Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls (Bone Health)
| Tracking Information | ||||
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| First Received Date ICMJE | September 17, 2009 | |||
| Last Updated Date | March 14, 2012 | |||
| Start Date ICMJE | February 2009 | |||
| Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
bone mass [ Time Frame: at baseline, at 5 months, at post-intervention ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00979511 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
bone area [ Time Frame: at baseline, at 5 months, at post-intervention ] | |||
| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls | |||
| Official Title ICMJE | The Effect of a 10-month School-based Provision of High-calcium Milk and Weight-bearing Exercise Program on the Bone Mineral Status of 7 to 9 Year Old Pre-pubertal Girls | |||
| Brief Summary | Osteoporosis has been described as a paediatric disease with a geriatric outcome. This is because bone mass is acquired during youth and is progressively lost later in life, without symptom or pain, until a fracture occurs. The proper management of osteoporosis includes improving bone mineral content in the first two decades of life so that reserves are built up before bone loss ensues. The investigators aim to determine the effect of a 10-month school-based provision of high-calcium milk and weight-bearing exercise program on the bone mineral status among prepubertal girls. The investigators' study is novel since it seeks to determine the effect of these interventions in girls, whose overall risks are much higher for osteoporosis later in life, and in a developing country population whose calcium intakes are more likely to be depleted. The investigators hypothesize that provision of either high-calcium milk or weight-bearing exercises will improve bone mineral density among prepubertal girls but that the bone accrual will be greater among those with both interventions. In addition, the investigators hypothesize that the changes will be more marked among those whose calcium intakes are lower. This study will use a two-by-two factorial design of 1) high-calcium milk (1000 mg/day) vs. placebo (115 mg/day) and 2) weight-bearing exercises (a total of 90 to 150 minutes per week divided into 3 to 5 schooldays) vs. no-exercise (passive activities) in a randomized controlled trial, for a total of 4 intervention groups: calcium+exercise, placebo+exercise, calcium+no exercise, placebo+no exercise. The study will be conducted among 80 prepubertal girls (on Tanner stage 1), aged 7-9 years and enrolled in one primary school in one of the metropolitan cities in the Philippines with an institution or a hospital with a Lunar Prodigy Central dual-energy x-ray absorptiometry (DEXA) machine. Osteoporosis has no treatment. The problem will continue to become burdensome in the future since population aging per se will increase the risk and incidence of fractures. Understanding the relationship between calcium and exercise is important since the greatest benefit is in the paediatric age range. The study results could provide information on a workable intervention that promotes the multiple health benefits of both exercise and high-calcium milk to young children. |
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| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Osteoporosis | |||
| Intervention ICMJE | Other: milk and exercise
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 120 | |||
| Completion Date | September 2010 | |||
| Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 7 Years to 9 Years (Child) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Philippines | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00979511 | |||
| Other Study ID Numbers ICMJE | 2009-01 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Cherry C. Maramag, Nutrition Center of the Philippines | |||
| Study Sponsor ICMJE | Nutrition Center of the Philippines | |||
| Collaborators ICMJE | Nestlé Foundation | |||
| Investigators ICMJE |
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| PRS Account | Nutrition Center of the Philippines | |||
| Verification Date | March 2012 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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