NCT01005381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

October 30, 2009

Last Update Submit

May 3, 2018

Conditions

Osteoporosis

Keywords

CalciumVitamin DParticle SizeAdolescentsBoneOsteoporosis

Outcome Measures

Primary Outcomes (2)

  • Calcium Balance

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

    weeks 2,3 + 5,6

  • Calcium Absorption

    Day 15, 30

Secondary Outcomes (4)

  • Serum parathyroid hormone suppression

    Day 19, 40

  • Serum 25-hydroxyvitamin D

    Day 1, 20, 2, 41

  • Urinary Calcium

    Weeks 2,3 + 5,6

  • Fecal Calcium

    Weeks 2,3 + 5,6

Study Arms (5)

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

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

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

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

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 SupplementDietary Supplement: Vitamin D

Interventions

Small Particle Size Calcium Carbonate SupplementDIETARY_SUPPLEMENT

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

No Vitamin D supplementSmall Particle Size Calcium CarbonateVitamin D supplement
Large Particle Size Calcium Carbonate SupplementDIETARY_SUPPLEMENT

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

Large Particle Size Calcium Carbonate
Vitamin DDIETARY_SUPPLEMENT

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

Vitamin D supplement
Calcium PlaceboDIETARY_SUPPLEMENT

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

Calcium Placebo

Eligibility Criteria

Age12 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • year old girls
  • Generally Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47906, United States

Location

Related Publications (1)

  • 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.

    PMID: 20962148DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Connie M Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Nutrition Science

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)