Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls (Bone Health)

Tracking Information
First Submitted Date ICMJE	September 17, 2009
First Posted Date ICMJE	September 18, 2009
Last Update Posted Date	March 15, 2012
Study Start Date ICMJE	February 2009
Actual Primary Completion Date	April 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 17, 2009)	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; (submitted: September 17, 2009)	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Osteoporosis
Intervention ICMJE	Other: milk and exercise; milk fortified with 1000mg calcium or low-calcium milk; weight-bearing exercise or passive exercise
Study Arms	Experimental: 1 Hi-Calcium milk & exercise Intervention: Other: milk and exercise; Experimental: 2 Hi-calcium milk with passive exercise Intervention: Other: milk and exercise; Experimental: 3Low-Calcium with exercise Intervention: Other: milk and exercise; Experimental: 4 Low-calcium milk with passive exercise Intervention: Other: milk and exercise
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 17, 2009)	120
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2010
Actual Primary Completion Date	April 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: pre-pubertal girls on Tanner stage 1; enrolled in study school; no diagnosed disorders; not taking medications that affects bone metabolism or weight-bearing exercise Exclusion Criteria: not meeting the inclusion criteria
Sex/Gender	Sexes Eligible for Study: Female
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	Principal Investigator: Pura R Solon, MD Clinical Research Scientist
PRS Account	Nutrition Center of the Philippines
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP