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

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

MedlinePlus related topics: Calcium Obesity Urine and Urination
Drug Information available for: Ergocalciferol Cholecalciferol Vitamin D
U.S. FDA Resources
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

Further study details as provided by Weill Medical College of Cornell University:

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

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

Estimated Enrollment: 60
Study Start Date: February 2006
Estimated Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288873

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Emily M Stein, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

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

Keywords provided by Weill Medical College of Cornell University:
Vitamin D deficiency
Secondary hyperparathyroidism
Obesity

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009