Encouraging Calcium Absorption and Bone Formation During Early Puberty

July 23, 2015 updated by: Steve Abrams, MD, Baylor College of Medicine

Optimization of Calcium Absorption and Bone Formation During Early Puberty

Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. The purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (NDO) or simple sugar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect increased bone mass. This study will examine if adding NDO to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. The study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth.

This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable kinetic study measuring calcium absorption will be performed. Participants will then be randomly assigned to receive calcium fortified food with or without added NDO for 1 year. Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic, hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA scan will be performed at the end of 2 years.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center at Baylor College of Medicine

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

9 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • Tanner Stage 2 or 3
  • Girls must not have started menstruating
  • In the 10th to 90th percentile in body mass index (BMI) for their age

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: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Steven A. Abrams, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 14, 2001

First Submitted That Met QC Criteria

August 15, 2001

First Posted (Estimate)

August 16, 2001

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR043740 (U.S. NIH Grant/Contract)

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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