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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00288873 |
Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels of vitamin D. These hormones are important in regulation of the body’s calcium stores and bone health. We would like to investigate these abnormalities and the accuracy of our current diagnostic tests by comparing results of standard assays for vitamin D and PTH to more specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also compare two standard vitamin D replacement regimens to determine if one is more effective.
This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using two different assays in obese subjects who have normal vitamin D and those who do not. We plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin D insufficiency. All subjects will fill out questionnaires about the amount of calcium and vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and the different forms of PTH.
Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight weeks, these subjects will fill out the above questionnaires and have the blood tests repeated. For safety purposes, urine calcium will also be monitored.
Condition | Intervention | Phase |
---|---|---|
Vitamin D Deficiency Secondary Hyperparathyroidism Obesity |
Drug: Ergocalciferol Drug: Cholecalciferol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity |
Estimated Enrollment: | 60 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10021 |
Principal Investigator: | Emily M Stein, M.D. | Weill Medical College of Cornell University |
Study ID Numbers: | 0509008122 |
Study First Received: | February 6, 2006 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00288873 History of Changes |
Health Authority: | United States: Institutional Review Board |
Vitamin D deficiency Secondary hyperparathyroidism Obesity |
Vitamin D Deficiency Cholecalciferol Obesity Parathyroid Diseases Avitaminosis Ergocalciferols Endocrine System Diseases Bone Density Conservation Agents Trace Elements Overweight Body Weight Signs and Symptoms |
Hyperparathyroidism, Secondary Vitamin D Malnutrition Hyperparathyroidism Vitamins Neoplasm Metastasis Nutrition Disorders Overnutrition Micronutrients Endocrinopathy Deficiency Diseases |
Parathyroid Diseases Avitaminosis Physiological Effects of Drugs Bone Density Conservation Agents Overweight Body Weight Signs and Symptoms Neoplastic Processes Hyperparathyroidism, Secondary Pathologic Processes Malnutrition Vitamins Neoplasm Metastasis Nutrition Disorders |
Micronutrients Deficiency Diseases Vitamin D Deficiency Obesity Cholecalciferol Growth Substances Ergocalciferols Endocrine System Diseases Pharmacologic Actions Neoplasms Vitamin D Hyperparathyroidism Overnutrition |