Working… Menu

Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288873
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : December 20, 2018
Information provided by:
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Secondary Hyperparathyroidism Obesity Drug: Ergocalciferol Drug: Cholecalciferol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Primary Outcome Measures :
  1. Vitamin D (25OHD):RIA and HPLC
  2. Parathyroid hormone (PTH):iPTH and 3rd generation RIA

Secondary Outcome Measures :
  1. Parathyroid hormone carboxy terminal fragment levels PTH(7-84)
  2. Ratio of PTH (1-84) to PTH (7-84)
  3. Serum calcium level
  4. Urine calcium level

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00288873

Layout table for location information
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Layout table for investigator information
Principal Investigator: Emily M Stein, M.D. Weill Medical College of Cornell University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00288873     History of Changes
Other Study ID Numbers: 0509008122
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Keywords provided by Weill Medical College of Cornell University:
Vitamin D deficiency
Secondary hyperparathyroidism
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Hyperparathyroidism, Secondary
Nutrition Disorders
Body Weight
Signs and Symptoms
Deficiency Diseases
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents