Study to Observe the Capability to Absorb Calcium as an Measure of Adequate Levels of Vitamin D
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Calcium Absorption Efficiency As An Indicator For Vitamin D Sufficiency|
- To determine the level of 25OHD that maximizes calcium absorption efficiency. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To describe the dose response curve of calcium absorption to vitamin D intake and serum 25OHD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Post Menopausal
post menopausal women between the ages 50-70 yrs.
Other: Dual isotope technique
Dual isotope technique using stable isotopes
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119378
|Contact: John F Aloia, MDfirstname.lastname@example.org|
|Contact: Mageda Mikhail, MD||516-663-8793||MMikhail@Winthrop.org|
|United States, New York|
|Winthrop University Hospital||Not yet recruiting|
|Mineola, New York, United States, 11501|
|Sub-Investigator: Mageda Mikhail, MD|
|Sub-Investigator: James Yeh, MD|
|Sub-Investigator: Padma Gadde, MD,MPH|
|Principal Investigator:||John F Aloia, MD||Winthrop University Hospital|