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

March 14, 2012 updated by: Cherry C. Maramag, Nutrition Center of the Philippines

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone mass
Time Frame: at baseline, at 5 months, at post-intervention
at baseline, at 5 months, at post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
bone area
Time Frame: at baseline, at 5 months, at post-intervention
at baseline, at 5 months, at post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutrition Center of the Philippines

Collaborators

Nestlé Foundation

Investigators

  • Principal Investigator: Pura R Solon, MD, Clinical Research Scientist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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