PostmenopausalNCT01119378
Study to Observe the Capability to Absorb Calcium as an Measure of Adequate Levels of Vitamin D
A study testing Dual isotope technique in people with Postmenopausal and Vitamin D Deficiency, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the capability to absorb calcium as a measure of the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women between the ages 50 and 70yrs. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal, Vitamin D Deficiency
- What is being tested?
- Dual isotope technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2013
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post menopausal women between the ages 50-70 yrs.
Who cannot join
- Any chronic medical illness including diabetes mellitus, history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
- Subjects with a BMI >35kg/m2
- Use of medication that influences vitamin D and bone metabolism (i.e. anticonvulsant medications, glucocorticoids, HAART [AIDS treatment], antirejection medications, high dose diuretics etc).
- Significant deviation from normal either in history, physical examination, or laboratory tests as evaluated by the primary investigator.
- Patients with a history of hypercalciuria ( Urine calcium:creatinine ratio > 0.37 , hypercalcemia ( serum calcium >10.21, nephrolithiasis, and active sarcoidosis will also be excluded.
- Unexplained weight loss >15% during the previous year or history of anorexia nervosa
Show all 13Show fewer
- Participation in another investigational trial in the past 30 days prior to the screening evaluation.
- Patients reporting alcohol intake greater than 2 drinks daily.
- Subjects with baseline 25-OHD level greater than 70 nmol /L will be excluded.
- Smokers greater than one pack per day will be excluded
- Dietary calcium intake greater than 2000 mg will be excluded
- Participants who have history of allergy to milk, gluten or orange juice will be excluded
- Participants willing not to forego multivitamins and vitamin D supplements during the study -
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: Calcium Absorption Efficiency As An Indicator For Vitamin D Sufficiency
The purpose of this study is to determine the capability to absorb calcium as a measure of the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women between the ages 50 and 70yrs. Subjects will have a screening visit, first and final visits. Subjects will be randomly assigned to a placebo or daily doses of vitamin D3. The specific aim of this study is to determine the level of vitamin D that will maximize the absorption of calcium and establish the relationship between the administered calcium dose and the actual absorbed calcium dose versus administered dose of Vitamin D and the serum levels of Vitamin D.
Read the detailed description
The specific aims of this project are:
- To determine the level of 25OHD that maximizes calcium absorption efficiency.
- To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD.
This will be a randomized, double-blind, placebo-controlled trial of healthy postmenopausal females to determine the individual and combined effects of calcium and vitamin D supplementation.70 female participants, ages 50 to 70 years of age who are menopausal for over 1 year will be recruited into the study . The patients participation in this study will last about 10 weeks. Approximately 70 subjects from Winthrop University Hospital and the surrounding area will participate in this study. There is a total of 3 visits. Patients will be fasting for all visits. The first visit is a screening visit to determine if the patients qualify.
At visit 2, the patients will be given a light breakfast and asked to drink an 8 ounce glass of milk or calcium fortified orange juice containing a calcium isotope. After breakfast, the doctor or nurse will start an intravenous infusion and inject the patient with an IV solution containing a calcium isotope. This is a stable calcium isotope that is not radioactive and has no known toxicity. The patients will also be asked to collect a 24 hour urine and return it to us the next day.
The volunteers will be divided into four groups:
The first group will take 800 iu daily of vitamin D supplementation. The second group will take 2000 iu daily of vitamin D.The third group will take 4000 iu vitamin D and the fourth group will only take placebos. Visit 3 is essentially the same as visit 2, with subjects returning unused study medication and given new tablets
Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and NutritionPro analysis software. Patients will be asked to refrain from taking other vitamin D supplements and to continue their usual calcium intake.
- Conditions
- Postmenopausal, Vitamin D Deficiency
- Being tested
- Dual isotope technique
- Keywords
- Post menopausal, Vitamin D sufficiency, Calcium absorption efficiency, Dual isotope technique
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual isotope techniqueOther
Also called Kinetic study, dual stable isotope
Dual isotope technique using stable isotopes
| Study group | Role | What they receive |
|---|---|---|
| Post Menopausal | Experimental | post menopausal women between the ages 50-70 yrs. Receives: Other: Dual isotope technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the level of 25OHD that maximizes calcium absorption efficiency.
Measured: 3 months
Secondary outcomes (1)
To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
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 PostmenopausalStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John F. Aloia, MD, Winthrop University Hospital
- Investigators
- John F Aloia, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119378
- Sponsor's protocol ID
- 10003
- Status last verified
- Dec 2014
- First submitted
- 5 May 2010
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Aloia JF, Dhaliwal R, Shieh A, Mikhail M, Fazzari M, Ragolia L, Abrams SA. Vitamin D supplementation increases calcium absorption without a threshold effect. Am J Clin Nutr. 2014 Mar;99(3):624-31. doi: 10.3945/ajcn.113.067199. Epub 2013 Dec 11.
PubMed 24335055
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Absorption Efficiency As An Indicator For Vitamin D Sufficiency
- ClinicalTrials.gov ID
- NCT01119378
- Acronym / sponsor ID
- 10003
- Conditions
- Postmenopausal, Vitamin D Deficiency
- Keywords
- Post menopausal, Vitamin D sufficiency, Calcium absorption efficiency, Dual isotope technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 May 2010 (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 determine the capability to absorb calcium as a measure of the sufficient levels of Vitamin D. Calcium absorption will be measured at baseline and after vitamin D3, by dual calcium isotope technique using stable isotopes in post menopausal women between the ages 50 and 70yrs. Subjects will have a screening visit, first and final visits. Subjects will be randomly assigned to a placebo or daily doses of vitamin D3. The specific aim of this study is to determine the level of vitamin D that will maximize the absorption of calcium and establish the relationship between the administered calcium dose and the actual absorbed calcium dose versus administered dose of Vitamin D and the serum levels of Vitamin D.
Detailed description
The specific aims of this project are:
- To determine the level of 25OHD that maximizes calcium absorption efficiency.
- To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD.
This will be a randomized, double-blind, placebo-controlled trial of healthy postmenopausal females to determine the individual and combined effects of calcium and vitamin D supplementation.70 female participants, ages 50 to 70 years of age who are menopausal for over 1 year will be recruited into the study . The patients participation in this study will last about 10 weeks. Approximately 70 subjects from Winthrop University Hospital and the surrounding area will participate in this study. There is a total of 3 visits. Patients will be fasting for all visits. The first visit is a screening visit to determine if the patients qualify.
At visit 2, the patients will be given a light breakfast and asked to drink an 8 ounce glass of milk or calcium fortified orange juice containing a calcium isotope. After breakfast, the doctor or nurse will start an intravenous infusion and inject the patient with an IV solution containing a calcium isotope. This is a stable calcium isotope that is not radioactive and has no known toxicity. The patients will also be asked to collect a 24 hour urine and return it to us the next day.
The volunteers will be divided into four groups:
The first group will take 800 iu daily of vitamin D supplementation. The second group will take 2000 iu daily of vitamin D.The third group will take 4000 iu vitamin D and the fourth group will only take placebos. Visit 3 is essentially the same as visit 2, with subjects returning unused study medication and given new tablets
Food frequency questionnaires will be filled out at the initial visit and final visit. Diet will be assessed using 3-day diet history form and NutritionPro analysis software. Patients will be asked to refrain from taking other vitamin D supplements and to continue their usual calcium intake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Menopausal | Experimental | Other: Dual isotope techniquepost menopausal women between the ages 50-70 yrs. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post menopausal women between the ages 50-70 yrs.
Key exclusion criteria (13 listed)
- Any chronic medical illness including diabetes mellitus, history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination.
- Subjects with a BMI >35kg/m2
- Use of medication that influences vitamin D and bone metabolism (i.e. anticonvulsant medications, glucocorticoids, HAART [AIDS treatment], antirejection medications, high dose diuretics etc).
- Significant deviation from normal either in history, physical examination, or laboratory tests as evaluated by the primary investigator.
- Patients with a history of hypercalciuria ( Urine calcium:creatinine ratio > 0.37 , hypercalcemia ( serum calcium >10.21, nephrolithiasis, and active sarcoidosis will also be excluded.
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 |
|---|---|---|
| Dual isotope techniqueAlso: Kinetic study, dual stable isotopeDual isotope technique using stable isotopes | Other | Post Menopausal |
Primary outcome
To determine the level of 25OHD that maximizes calcium absorption efficiency.
Time frame: 3 months
1 secondary outcome
To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD
Time frame: 3 months
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 31 Dec 2014.
- Derived from this study: PubMed 24335055Aloia JF, Dhaliwal R, Shieh A, Mikhail M, Fazzari M, Ragolia L, Abrams SA. Vitamin D supplementation increases calcium absorption without a threshold effect. Am J Clin Nutr. 2014 Mar;99(3):624-31. doi: 10.3945/ajcn.113.067199. Epub 2013 Dec 11.
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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.
John F Aloia, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual isotope technique in people with Postmenopausal and Vitamin D Deficiency, run by Winthrop University Hospital 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 13 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 31 Dec 2014. 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?
To determine the level of 25OHD that maximizes calcium absorption efficiency. (time frame: 3 months). 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 NCT01119378, 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 31 Dec 2014.