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Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity

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ClinicalTrials.gov Identifier: NCT00288873
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : December 20, 2018
Sponsor:
Information provided by:
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date December 20, 2018
Study Start Date  ICMJE February 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • Vitamin D (25OHD):RIA and HPLC
  • Parathyroid hormone (PTH):iPTH and 3rd generation RIA
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00288873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
  • Parathyroid hormone carboxy terminal fragment levels PTH(7-84)
  • Ratio of PTH (1-84) to PTH (7-84)
  • Serum calcium level
  • Urine calcium level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
Official Title  ICMJE Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin D Deficiency
  • Secondary Hyperparathyroidism
  • Obesity
Intervention  ICMJE
  • Drug: Ergocalciferol
  • Drug: Cholecalciferol
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1111/j.1365-2265.2008.03470.x. Epub 2008 Nov 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2006)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288873
Other Study ID Numbers  ICMJE 0509008122
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily M Stein, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2018

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