Study to Observe the Capability to Absorb Calcium as an Measure of Adequate Levels of Vitamin D

Completed · Not applicable

Conditions studied: Postmenopausal, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT01119378

Run by

Winthrop University Hospital

People needed

76

Starts

2010-12-01

Expected to finish

2013-12-01

Last updated by the study team

2014-12-31

Who can join

Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Post menopausal women between the ages 50-70 yrs.

You may not qualify if…

• 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
• 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 -

Where it is running

• Winthrop University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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