OsteoporosisNCT01005381
Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls
A study testing Small Particle Size Calcium Carbonate Supplement, Large Particle Size Calcium Carbonate Supplement and Vitamin D in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Small Particle Size Calcium Carbonate Supplement, Large Particle Size Calcium Carbonate Supplement and Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 12-14 year old girls
- Generally Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters 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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Small Particle Size Calcium Carbonate Supplement, Large Particle Size Calcium Carbonate Supplement, Vitamin D, Calcium Placebo
- Keywords
- Calcium, Vitamin D, Particle Size, Adolescents, Bone, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Large Particle Size Calcium Carbonate SupplementDietary supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Vitamin DDietary supplement
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
Calcium PlaceboDietary supplement
Placebo tablets identical to the large and small particle size calcium carbonate tablets.
Given twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Small Particle Size Calcium Carbonate | Experimental | Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement). Receives: 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). Receives: 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. Receives: Dietary Supplement: Calcium Placebo |
| No Vitamin D supplement | Active comparator | Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement). Receives: 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. Receives: Dietary Supplement: Small Particle Size Calcium Carbonate Supplement; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Balance
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Measured: weeks 2,3 + 5,6
Calcium Absorption
Measured: Day 15, 30
Secondary outcomes (4)
Serum parathyroid hormone suppression
Serum PTH will be measured by a 2-site immunoassay
Measured: Day 19, 40
Serum 25-hydroxyvitamin D
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Measured: Day 1, 20, 2, 41
Urinary Calcium
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Measured: Weeks 2,3 + 5,6
Fecal Calcium
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry
Measured: Weeks 2,3 + 5,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJun 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie M Weaver, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005381
- Sponsor's protocol ID
- 0609004386
- Status last verified
- May 2018
- First submitted
- 30 Oct 2009
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20962148
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls
- ClinicalTrials.gov ID
- NCT01005381
- Acronym / sponsor ID
- 0609004386
- Conditions
- Osteoporosis
- Keywords
- Calcium, Vitamin D, Particle Size, Adolescents, Bone, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Small Particle Size Calcium Carbonate | Experimental | Dietary Supplement: Small Particle Size Calcium Carbonate SupplementSubjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement). |
| Large Particle Size Calcium Carbonate | Active comparator | Dietary Supplement: Large Particle Size Calcium Carbonate SupplementSubjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement). |
| Calcium Placebo | Placebo comparator | Dietary Supplement: Calcium PlaceboSubjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements. |
| No Vitamin D supplement | Active comparator | Dietary Supplement: Small Particle Size Calcium Carbonate SupplementSubjects are given calcium carbonate supplement once daily (325 mg/d from supplement). |
| Vitamin D supplement | Experimental | Dietary Supplement: Small Particle Size Calcium Carbonate Supplement, Dietary Supplement: Vitamin DSubjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 12-14 year old girls
- Generally Healthy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Particle Size Calcium Carbonate SupplementSmall Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm. | Dietary supplement | No Vitamin D supplement, Small Particle Size Calcium Carbonate, Vitamin D supplement |
| Large Particle Size Calcium Carbonate SupplementLarge Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily. | Dietary supplement | Large Particle Size Calcium Carbonate |
| Vitamin DVitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily. | Dietary supplement | Vitamin D supplement |
| Calcium PlaceboPlacebo tablets identical to the large and small particle size calcium carbonate tablets. Given twice daily. | Dietary supplement | Calcium Placebo |
Primary outcome
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)
Calcium Absorption
Time frame: Day 15, 30
4 secondary outcomes
Serum parathyroid hormone suppression
Time frame: Day 19, 40
Serum 25-hydroxyvitamin D
Time frame: Day 1, 20, 2, 41
Urinary Calcium
Time frame: Weeks 2,3 + 5,6
Fecal Calcium
Time frame: Weeks 2,3 + 5,6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 20962148Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie M Weaver, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Particle Size Calcium Carbonate Supplement, Large Particle Size Calcium Carbonate Supplement and Vitamin D in people with Osteoporosis, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium Balance (time frame: weeks 2,3 + 5,6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.