Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
|ClinicalTrials.gov Identifier: NCT00288873|
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : December 20, 2018
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 or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Secondary Hyperparathyroidism Obesity||Drug: Ergocalciferol Drug: Cholecalciferol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Vitamin D (25OHD):RIA and HPLC
- Parathyroid hormone (PTH):iPTH and 3rd generation RIA
- Parathyroid hormone carboxy terminal fragment levels PTH(7-84)
- Ratio of PTH (1-84) to PTH (7-84)
- Serum calcium level
- Urine calcium level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288873
|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|