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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
milk and exercise
Sponsored by
Nutrition Center of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, calcium, weight-bearing exercise, bone mass, prepubertal girls

Eligibility Criteria

7 Years - 9 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Public school

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1 Hi-Calcium milk & exercise

2 Hi-calcium milk with passive exercise

3Low-Calcium with exercise

4 Low-calcium milk with passive exercise

Arm Description

Outcomes

Primary Outcome Measures

bone mass

Secondary Outcome Measures

bone area

Full Information

First Posted
September 17, 2009
Last Updated
March 14, 2012
Sponsor
Nutrition Center of the Philippines
Collaborators
Nestlé Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00979511
Brief Title
Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls
Acronym
Bone Health
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nutrition Center of the Philippines
Collaborators
Nestlé Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, calcium, weight-bearing exercise, bone mass, prepubertal girls

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Hi-Calcium milk & exercise
Arm Type
Experimental
Arm Title
2 Hi-calcium milk with passive exercise
Arm Type
Experimental
Arm Title
3Low-Calcium with exercise
Arm Type
Experimental
Arm Title
4 Low-calcium milk with passive exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
milk and exercise
Intervention Description
milk fortified with 1000mg calcium or low-calcium milk weight-bearing exercise or passive exercise
Primary Outcome Measure Information:
Title
bone mass
Time Frame
at baseline, at 5 months, at post-intervention
Secondary Outcome Measure Information:
Title
bone area
Time Frame
at baseline, at 5 months, at post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pura R Solon, MD
Organizational Affiliation
Clinical Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public school
City
Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

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

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