OsteoporosisNCT01277185
Calcium Metabolism in Mexican American Adolescents
A study testing Low Calcium Diet and High Calcium Diet in people with Osteoporosis, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this study is to identify calcium metabolism characteristics in Mexican American adolescents. The investigators predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Low Calcium Diet and High Calcium Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2010
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal, healthy adolescents of Mexican American descent
- Mexican American boys age 13-15
- Mexican American girls age 12-14
Who cannot join
- Malabsorptive disorders
- Anemia
- Smoking
- History of medications known to affect calcium metabolism
- Body weight outside 85-120% of ideal body weight for height
- Regular consumption of illegal drugs
- Contraceptive use
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify calcium metabolism characteristics in Mexican American adolescents. The investigators predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.
Read the detailed description
Previously significant racial and sex differences in calcium retention and kinetics in adolescents has been found. Other minority groups have increased calcium absorption efficiency at low calcium intakes in contrast to white adolescents. Since Hispanics and specifically Mexican Americans will soon comprise an increasing proportion of our population. We propose to identify calcium metabolism characteristics in this group. We predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.
Thus the specific aims of this project include:
- to establish calcium requirements
- to establish the relationship between calcium intake and calcium absorption
- to identify the major physiological parameters(kidney, intestine, bone) that contribute to calcium retention in Mexican-American adolescents
During this two-phase metabolic camp participants will consume either a higher calcium diet(1100-2300mg/d) or a lower calcium diet (600-1200mg/d) during the first 3-week phase and switch to the opposite regime during the second 3-week phase, with a 2-week washout period in between. Subjects will collect all excreta during both phases. Calcium absorption, height, weight, and bone density will evaluated throughout the 6-week period of the study.
- Conditions
- Osteoporosis
- Being tested
- Low Calcium Diet, High Calcium Diet
- Keywords
- calcium, healthy, Mexican-American adolescents, camp, girls, boys, bone
- Medical subject headings
- Osteoporosis, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calcium DietDietary supplement
The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a lower (600-1200 mg/d)level of calcium in the first camp followed by the opposite (higher calcium diet)regime in the second camp.
High Calcium DietDietary supplement
The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a higher (1100-2300mg/d)level of calcium in the first camp followed by the opposite (lower calcium diet)regime in the second camp.
| Study group | Role | What they receive |
|---|---|---|
| Low Calcium Diet (600-1200 mg/d) | Active comparator | Not described Receives: Dietary Supplement: Low Calcium Diet |
| High Calcium Diet (1100-2300mg/d) | Active comparator | Not described Receives: Dietary Supplement: High Calcium Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Absorption and Retention
Measured: June 2010-July 2010
Secondary outcomes (1)
Bone Density
Measured: June 2010-July 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Berdine Martin, Purdue University
- Investigators
- Connie Weaver, PhD, Principal investigator, Purdue UniversityBerdine Martin, PhD, Study director, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277185
- Sponsor's protocol ID
- Camp Calcium 11
- Other IDs
- 1R01HD061908-01A2
- Status last verified
- May 2018
- First submitted
- 12 Jan 2011
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Palacios C, Martin BR, McCabe GP, McCabe L, Peacock M, Weaver CM. Dietary calcium requirements do not differ between Mexican-American boys and girls. J Nutr. 2014 Aug;144(8):1167-73. doi: 10.3945/jn.113.188318. Epub 2014 May 28.
PubMed 24872223
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 Mexican American Adolescents
- ClinicalTrials.gov ID
- NCT01277185
- Acronym / sponsor ID
- Camp Calcium 11
- Conditions
- Osteoporosis
- Keywords
- calcium, healthy, Mexican-American adolescents, camp, girls, boys, bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jan 2011 (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.
The purpose of this study is to identify calcium metabolism characteristics in Mexican American adolescents. The investigators predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.
Detailed description
Previously significant racial and sex differences in calcium retention and kinetics in adolescents has been found. Other minority groups have increased calcium absorption efficiency at low calcium intakes in contrast to white adolescents. Since Hispanics and specifically Mexican Americans will soon comprise an increasing proportion of our population. We propose to identify calcium metabolism characteristics in this group. We predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.
Thus the specific aims of this project include:
- to establish calcium requirements
- to establish the relationship between calcium intake and calcium absorption
- to identify the major physiological parameters(kidney, intestine, bone) that contribute to calcium retention in Mexican-American adolescents
During this two-phase metabolic camp participants will consume either a higher calcium diet(1100-2300mg/d) or a lower calcium diet (600-1200mg/d) during the first 3-week phase and switch to the opposite regime during the second 3-week phase, with a 2-week washout period in between. Subjects will collect all excreta during both phases. Calcium absorption, height, weight, and bone density will evaluated throughout the 6-week period of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Calcium Diet (600-1200 mg/d) | Active comparator | Dietary Supplement: Low Calcium Diet |
| High Calcium Diet (1100-2300mg/d) | Active comparator | Dietary Supplement: High Calcium Diet |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Normal, healthy adolescents of Mexican American descent
- Mexican American boys age 13-15
- Mexican American girls age 12-14
Key exclusion criteria (8 listed)
- Malabsorptive disorders
- Anemia
- Smoking
- History of medications known to affect calcium metabolism
- Body weight outside 85-120% of ideal body weight for height
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 |
|---|---|---|
| Low Calcium DietThe basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a lower (600-1200 mg/d)level of calcium in the first camp followed by the opposite (higher calcium diet)regime in the second camp. | Dietary supplement | Low Calcium Diet (600-1200 mg/d) |
| High Calcium DietThe basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a higher (1100-2300mg/d)level of calcium in the first camp followed by the opposite (lower calcium diet)regime in the second camp. | Dietary supplement | High Calcium Diet (1100-2300mg/d) |
Primary outcome
Calcium Absorption and Retention
Time frame: June 2010-July 2010
1 secondary outcome
Bone Density
Time frame: June 2010-July 2010
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 24872223Palacios C, Martin BR, McCabe GP, McCabe L, Peacock M, Weaver CM. Dietary calcium requirements do not differ between Mexican-American boys and girls. J Nutr. 2014 Aug;144(8):1167-73. doi: 10.3945/jn.113.188318. Epub 2014 May 28.
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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 Weaver, PhD principal investigator
Purdue University
Berdine Martin, PhD study director
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 Low Calcium Diet and High Calcium Diet 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 3 inclusion and 8 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 Absorption and Retention (time frame: June 2010-July 2010). 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 NCT01277185, 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.