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

This study has been completed.
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
Cherry C. Maramag, Nutrition Center of the Philippines
ClinicalTrials.gov Identifier:
NCT00979511
First received: September 17, 2009
Last updated: March 14, 2012
Last verified: March 2012

September 17, 2009
March 14, 2012
February 2009
April 2010   (final data collection date for primary outcome measure)
bone mass [ Time Frame: at baseline, at 5 months, at post-intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00979511 on ClinicalTrials.gov Archive Site
bone area [ Time Frame: at baseline, at 5 months, at post-intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Osteoporosis
Other: milk and exercise
  • milk fortified with 1000mg calcium or low-calcium milk
  • weight-bearing exercise or passive exercise
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
7 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT00979511
2009-01
No
Cherry C. Maramag, Nutrition Center of the Philippines
Nutrition Center of the Philippines
Nestlé Foundation
Principal Investigator: Pura R Solon, MD Clinical Research Scientist
Nutrition Center of the Philippines
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP