Bone MineralizationNCT00591708
Calcium Metabolism in Asian Adolescents
A study testing Beverage containing calcium citrate malate and Beverage fortified with calcium citrate malate in people with Bone Mineralization and Adolescent Development, run by Purdue University at 1 site in United States.
Trial summary
Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Bone Mineralization, Adolescent Development
- What is being tested?
- Beverage containing calcium citrate malate and Beverage fortified with calcium citrate malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 2005
- 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy teens of Asian descent
Who cannot join
- malabsorptive disorders
- anemia
- smoking, illegal drugs
- oral contraceptives
- pregnancy
- drugs that influence calcium metabolism
- body weight for height greater than 85 percentile
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Foods and Nutrition, Purdue University
West Lafayette, Indiana, 47907-2059
About this study
Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass.
Read the detailed description
Adolescent Asian boys and girls will consume a controlled diet for two three-week periods. The basal diet will contain 600 mg/d calcium and will be supplemented with beverages fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d. Each participant will be studied on one of four combinations of a lower and a higher calcium intake within that range in a cross-over design.
- Conditions
- Bone Mineralization, Adolescent Development
- Being tested
- Beverage containing calcium citrate malate, Beverage fortified with calcium citrate malate
- Keywords
- calcium, bone, bone density, adolescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage containing calcium citrate malateDietary supplement
Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
Beverage fortified with calcium citrate malateDietary supplement
Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | Supplementation of a higher level of calcium (500-1300 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected. Receives: Dietary Supplement: Beverage fortified with calcium citrate malate |
| A | Experimental | Supplementation of a lower level of calcium (0-400 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected. Receives: Dietary Supplement: Beverage containing calcium citrate malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium retention (mg/d)
Measured: Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.
Secondary outcomes (1)
Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium)
Measured: Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJul 2004
- Primary completionAug 2005
- Study completionAug 2005
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 Bone MineralizationStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie Weaver, PhD, Principal investigator, Department of Foods and Nutrition, Purdue UniversityBerdine R Martin, PhD, Study director, Department of Foods and Nutrition, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591708
- Sponsor's protocol ID
- AR40553
- Other IDs
- R01AR040553
- Status last verified
- May 2018
- First submitted
- 26 Dec 2007
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu L, Martin BR, Braun MM, Wastney ME, McCabe GP, McCabe LD, DiMeglio LA, Peacock M, Weaver CM. Calcium requirements and metabolism in Chinese-American boys and girls. J Bone Miner Res. 2010 Aug;25(8):1842-9. doi: 10.1002/jbmr.76.
PubMed 20205166
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
- Calcium Metabolism in Asian Adolescents
- ClinicalTrials.gov ID
- NCT00591708
- Acronym / sponsor ID
- AR40553
- Conditions
- Bone Mineralization, Adolescent Development
- Keywords
- calcium, bone, bone density, adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 11 Jan 2008 (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.
Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass.
Detailed description
Adolescent Asian boys and girls will consume a controlled diet for two three-week periods. The basal diet will contain 600 mg/d calcium and will be supplemented with beverages fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d. Each participant will be studied on one of four combinations of a lower and a higher calcium intake within that range in a cross-over design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Dietary Supplement: Beverage fortified with calcium citrate malateSupplementation of a higher level of calcium (500-1300 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected. |
| A | Experimental | Dietary Supplement: Beverage containing calcium citrate malateSupplementation of a lower level of calcium (0-400 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy teens of Asian descent
Key exclusion criteria (7 listed)
- malabsorptive disorders
- anemia
- smoking, illegal drugs
- oral contraceptives
- 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 |
|---|---|---|
| Beverage containing calcium citrate malateBeverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days. | Dietary supplement | A |
| Beverage fortified with calcium citrate malateBeverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days. | Dietary supplement | B |
Primary outcome
Calcium retention (mg/d)
Time frame: Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.
1 secondary outcome
Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium)
Time frame: Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption
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 20205166Wu L, Martin BR, Braun MM, Wastney ME, McCabe GP, McCabe LD, DiMeglio LA, Peacock M, Weaver CM. Calcium requirements and metabolism in Chinese-American boys and girls. J Bone Miner Res. 2010 Aug;25(8):1842-9. doi: 10.1002/jbmr.76.
Related trials for Bone Mineralization
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
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 Weaver, PhD principal investigator
Department of Foods and Nutrition, Purdue University
Berdine R Martin, PhD study director
Department of Foods and Nutrition, 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 Beverage containing calcium citrate malate and Beverage fortified with calcium citrate malate in people with Bone Mineralization and Adolescent Development, 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 1 inclusion and 7 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. 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 retention (mg/d) (time frame: Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.). 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 NCT00591708, 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.