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Clinical Trials/NCT00979511
NCT00979511CompletedNot Applicable

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

Nutrition Center of the Philippines2 sites in 1 country120 target enrollmentStarted: February 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
bone mass

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
7 Years to 9 Years (Child)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

bone mass

Time Frame: at baseline, at 5 months, at post-intervention

Secondary Outcomes

  • bone area(at baseline, at 5 months, at post-intervention)

Investigators

Sponsor
Nutrition Center of the Philippines
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cherry C. Maramag

Research Scientist

Nutrition Center of the Philippines

Study Sites (2)

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