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

This study has been completed.
Sponsor:
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01005381
First received: October 30, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoporosis
Dietary Supplement: Small Particle Size Calcium Carbonate Supplement
Dietary Supplement: Large Particle Size Calcium Carbonate Supplement
Dietary Supplement: Vitamin D
Dietary Supplement: Calcium Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Calcium Balance [ Time Frame: weeks 2,3 + 5,6 ] [ Designated as safety issue: No ]
  • Calcium Absorption [ Time Frame: Day 15, 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum parathyroid hormone suppression [ Time Frame: Day 19, 40 ] [ Designated as safety issue: Yes ]
  • Serum 25-hydroxyvitamin D [ Time Frame: Day 1, 20, 2, 41 ] [ Designated as safety issue: Yes ]
  • Urinary Calcium [ Time Frame: Weeks 2,3 + 5,6 ] [ Designated as safety issue: No ]
  • Fecal Calcium [ Time Frame: Weeks 2,3 + 5,6 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Small Particle Size Calcium Carbonate
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Dietary Supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Active Comparator: Large Particle Size Calcium Carbonate
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Dietary Supplement: Large Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Placebo Comparator: Calcium Placebo
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
Dietary Supplement: Calcium Placebo

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

Given twice daily.

Active Comparator: No Vitamin D supplement
Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
Dietary Supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Experimental: Vitamin D supplement
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
Dietary Supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Dietary Supplement: Vitamin D
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.

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:

  1. 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.
  2. 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.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005381

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47906
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Connie M Weaver, PhD Purdue University
  More Information

No publications provided by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Connie Weaver, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT01005381     History of Changes
Other Study ID Numbers: 0609004386
Study First Received: October 30, 2009
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Calcium
Vitamin D
Particle Size
Adolescents
Bone
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014