Study to Observe the Capability to Absorb Calcium as an Measure of Adequate Levels of Vitamin D
NCT ID: NCT01119378
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2010-12-31
2013-12-31
Brief Summary
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Detailed Description
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1. To determine the level of 25OHD that maximizes calcium absorption efficiency.
2. 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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
DOUBLE
Study Groups
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Post Menopausal
post menopausal women between the ages 50-70 yrs.
Dual isotope technique
Dual isotope technique using stable isotopes
Interventions
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Dual isotope technique
Dual isotope technique using stable isotopes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Subjects with a BMI \>35kg/m2
3. Use of medication that influences vitamin D and bone metabolism (i.e. anticonvulsant medications, glucocorticoids, HAART \[AIDS treatment\], antirejection medications, high dose diuretics etc).
4. Significant deviation from normal either in history, physical examination, or laboratory tests as evaluated by the primary investigator.
5. 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.
6. Unexplained weight loss \>15% during the previous year or history of anorexia nervosa
7. Participation in another investigational trial in the past 30 days prior to the screening evaluation.
8. Patients reporting alcohol intake greater than 2 drinks daily.
9. Subjects with baseline 25-OHD level greater than 70 nmol /L will be excluded.
10. Smokers greater than one pack per day will be excluded
11. Dietary calcium intake greater than 2000 mg will be excluded
12. Participants who have history of allergy to milk, gluten or orange juice will be excluded
13. Participants willing not to forego multivitamins and vitamin D supplements during the study -
50 Years
70 Years
FEMALE
Yes
Sponsors
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Winthrop University Hospital
OTHER
Responsible Party
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John F. Aloia, MD
Principal Investigator
Principal Investigators
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John F Aloia, MD
Role: PRINCIPAL_INVESTIGATOR
Winthrop University Hospital
Locations
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Winthrop University Hospital
Mineola, New York, United States
Countries
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References
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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.
Other Identifiers
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10003
Identifier Type: -
Identifier Source: org_study_id