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Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
This study is ongoing, but not recruiting participants.
Study NCT00288873   Information provided by Weill Medical College of Cornell University
First Received: February 6, 2006   Last Updated: July 19, 2007   History of Changes

February 6, 2006
July 19, 2007
February 2006
 
  • Vitamin D (25OHD):RIA and HPLC
  • Parathyroid hormone (PTH):iPTH and 3rd generation RIA
Same as current
Complete list of historical versions of study NCT00288873 on ClinicalTrials.gov Archive Site
  • Parathyroid hormone carboxy terminal fragment levels PTH(7-84)
  • Ratio of PTH (1-84) to PTH (7-84)
  • Serum calcium level
  • Urine calcium level
Same as current
 
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity

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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Vitamin D Deficiency
  • Secondary Hyperparathyroidism
  • Obesity
  • Drug: Ergocalciferol
  • Drug: Cholecalciferol
 
Stein EM, Strain G, Sinha N, Ortiz D, Pomp A, Dakin G, McMahon DJ, Bockman R, Silverberg SJ. Vitamin D insufficiency prior to bariatric surgery: risk factors and a pilot treatment study. Clin Endocrinol (Oxf). 2009 Aug;71(2):176-83. Epub 2008 Nov 5.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
60
July 2007
 

Inclusion Criteria:

  • Obese subjects with body mass indices greater than 40 kg/m2 or 35 kg/m2 with other medical conditions secondary to obesity
  • Willingness to take vitamin D supplements
  • If baseline vitamin D level is >25 ng/ml subjects will be eligible for the control group
  • If baseline vitamin D level is <25 ng/ml subjects will be eligible for one of the two vitamin D replacement groups

Exclusion Criteria:

  • Hypercalcemia
  • Kidney disease
  • Liver disease
  • Malabsorption
  • Prior diagnosis of bone disease
  • Medical conditions requiring daily use of calcium, antacids, or medications known to affect bone metabolism or interact with vitamin D
  • Hypersensitivity to any formulation of vitamin D
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00288873
 
0509008122
Weill Medical College of Cornell University
 
Principal Investigator: Emily M Stein, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP