Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls - Full Text View

Sponsor:	Purdue University
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT01005381

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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Calcium Dietary Supplements Diets Osteoporosis

Drug Information available for: Calcium gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

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
Small Particle Size Calcium Carbonate: Experimental 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.
Large Particle Size Calcium Carbonate: Active Comparator 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.
Calcium Placebo: Placebo Comparator 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.
No Vitamin D supplement: Active Comparator 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.
Vitamin D supplement: Experimental 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:

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.

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

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

Responsible Party:	Purdue University ( Connie Weaver, Principal Investigator )
Study ID Numbers:	0609004386
Study First Received:	October 30, 2009
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT01005381 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:

Calcium
Vitamin D
Particle Size

Adolescents
Bone
Osteoporosis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
Calcium Carbonate
Bone Diseases

Pharmacologic Actions
Calcium, Dietary
Vitamin D
Musculoskeletal Diseases
Vitamins
Osteoporosis, Postmenopausal
Antacids
Micronutrients

ClinicalTrials.gov processed this record on February 08, 2010