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
  Purpose

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.


Condition Intervention
Osteoporosis
Other: milk and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nutrition Center of the Philippines:

Primary Outcome Measures:
  • bone mass [ Time Frame: at baseline, at 5 months, at post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone area [ Time Frame: at baseline, at 5 months, at post-intervention ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Hi-Calcium milk & exercise Other: milk and exercise
  • milk fortified with 1000mg calcium or low-calcium milk
  • weight-bearing exercise or passive exercise
Experimental: 2 Hi-calcium milk with passive exercise Other: milk and exercise
  • milk fortified with 1000mg calcium or low-calcium milk
  • weight-bearing exercise or passive exercise
Experimental: 3Low-Calcium with exercise Other: milk and exercise
  • milk fortified with 1000mg calcium or low-calcium milk
  • weight-bearing exercise or passive exercise
Experimental: 4 Low-calcium milk with passive exercise Other: milk and exercise
  • milk fortified with 1000mg calcium or low-calcium milk
  • weight-bearing exercise or passive exercise

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979511

Locations
Philippines
Public school
Manila, Philippines, 1000
Sponsors and Collaborators
Nutrition Center of the Philippines
Nestlé Foundation
Investigators
Principal Investigator: Pura R Solon, MD Clinical Research Scientist
  More Information

No publications provided

Responsible Party: Cherry C. Maramag, Research Scientist, Nutrition Center of the Philippines
ClinicalTrials.gov Identifier: NCT00979511     History of Changes
Other Study ID Numbers: 2009-01
Study First Received: September 17, 2009
Last Updated: March 14, 2012
Health Authority: Phillippines: Ethics Committee

Keywords provided by Nutrition Center of the Philippines:
osteoporosis
calcium
weight-bearing exercise
bone mass
prepubertal girls

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014