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Completed

NCT Number: NCT01005381

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

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.

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Key information

Age range

12 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Small Particle Size Calcium Carbonate Supplement

Dietary Supplement

Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.

Large Particle Size Calcium Carbonate Supplement

Dietary Supplement

Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.

Vitamin D

Dietary Supplement

Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.

Calcium Placebo

Dietary Supplement

Placebo tablets identical to the large and small particle size calcium carbonate tablets.

Given twice daily.

Primary outcomes

  1. Calcium Balance

    Time frame: weeks 2,3 + 5,6

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

  2. Calcium Absorption

    Time frame: Day 15, 30

Secondary outcomes

  1. Serum parathyroid hormone suppression

    Time frame: Day 19, 40

    Serum PTH will be measured by a 2-site immunoassay

  2. Serum 25-hydroxyvitamin D

    Time frame: Day 1, 20, 2, 41

    Serum 25-hydroxyvitamin Dwill be measured by LCMS

  3. Urinary Calcium

    Time frame: Weeks 2,3 + 5,6

    Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry

  4. Fecal Calcium

    Time frame: Weeks 2,3 + 5,6

    Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Nov 2, 2009
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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