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Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement
Vitamin D
Calcium Placebo
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Calcium, Vitamin D, Particle Size, Adolescents, Bone, Osteoporosis

Eligibility Criteria

12 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 12-14 year old girls
  • Generally Healthy

Exclusion Criteria:

  • History of alcohol, smoking, or non-prescription drug use
  • Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism
  • Oral contraceptive use
  • Pregnancy

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Active Comparator

Experimental

Arm Label

Small Particle Size Calcium Carbonate

Large Particle Size Calcium Carbonate

Calcium Placebo

No Vitamin D supplement

Vitamin D supplement

Arm Description

Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).

Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).

Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.

Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).

Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.

Outcomes

Primary Outcome Measures

Calcium Balance
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Calcium Absorption

Secondary Outcome Measures

Serum parathyroid hormone suppression
Serum PTH will be measured by a 2-site immunoassay
Serum 25-hydroxyvitamin D
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Urinary Calcium
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Fecal Calcium
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry

Full Information

First Posted
October 30, 2009
Last Updated
May 3, 2018
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT01005381
Brief Title
Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls
Official Title
The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study has two research arms: The purpose of the 1st is to determine if a smaller particle size calcium carbonate supplement (than that which is now commercially available) improves calcium absorption and retention in adolescents girls. The purpose of the 2nd is to determine if vitamin D supplementation improves calcium absorption and retention in adolescents girls.
Detailed Description
An important strategy to reducing the risk for osteoporosis and fracture in later life is to optimize the development of peak bone mass during adolescence. Because calcium is the main mineral component of bone, maximizing calcium absorption and retention during adolescence is important to maximize peak bone mass. Our two research arms address two different mechanisms by which calcium absorption and retention may be increased: We hypothesize that a smaller particle size calcium carbonate supplement (than that which is now commercially available) may be better absorbed and lead to higher calcium retention in adolescents. We hypothesize that vitamin D supplementation will increased calcium absorption and retention in adolescents. Subjects will be assigned to one of the two research arms. 1)Small and large particle size calcium supplements or placebo or 2) calcium supplements with or without vitamin D supplements will be given to subjects during two 3-week study periods in which subjects live on-site. Calcium absorption will be measured by parathyroid hormone suppression after a calcium load and by stable calcium isotope in some subjects. Calcium retention will be measured by calcium intake minus calcium excretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Calcium, Vitamin D, Particle Size, Adolescents, Bone, Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Small Particle Size Calcium Carbonate
Arm Type
Experimental
Arm Description
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Arm Title
Large Particle Size Calcium Carbonate
Arm Type
Active Comparator
Arm Description
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Arm Title
Calcium Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
Arm Title
No Vitamin D supplement
Arm Type
Active Comparator
Arm Description
Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
Arm Title
Vitamin D supplement
Arm Type
Experimental
Arm Description
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Small Particle Size Calcium Carbonate Supplement
Intervention Description
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Large Particle Size Calcium Carbonate Supplement
Intervention Description
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Placebo
Intervention Description
Placebo tablets identical to the large and small particle size calcium carbonate tablets. Given twice daily.
Primary Outcome Measure Information:
Title
Calcium Balance
Description
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Time Frame
weeks 2,3 + 5,6
Title
Calcium Absorption
Time Frame
Day 15, 30
Secondary Outcome Measure Information:
Title
Serum parathyroid hormone suppression
Description
Serum PTH will be measured by a 2-site immunoassay
Time Frame
Day 19, 40
Title
Serum 25-hydroxyvitamin D
Description
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Time Frame
Day 1, 20, 2, 41
Title
Urinary Calcium
Description
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Time Frame
Weeks 2,3 + 5,6
Title
Fecal Calcium
Description
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry
Time Frame
Weeks 2,3 + 5,6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 12-14 year old girls Generally Healthy Exclusion Criteria: History of alcohol, smoking, or non-prescription drug use Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism Oral contraceptive use Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Weaver, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20962148
Citation
Park CY, Hill KM, Elble AE, Martin BR, DiMeglio LA, Peacock M, McCabe GP, Weaver CM. Daily supplementation with 25 mug cholecalciferol does not increase calcium absorption or skeletal retention in adolescent girls with low serum 25-hydroxyvitamin D. J Nutr. 2010 Dec;140(12):2139-44. doi: 10.3945/jn.110.124891. Epub 2010 Oct 20.
Results Reference
derived

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Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls

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