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NCT00288873 · ClinicalTrials.gov registry record · Phase 4
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
A Phase 4 study of Obesity and Vitamin D Deficiency, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00288873 is a Phase 4 study of Obesity and Vitamin D Deficiency that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 60 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00288873, a Phase 4 study of Obesity and Vitamin D Deficiency, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Ergocalciferol
- DRUG Cholecalciferol
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00288873
The ClinicalTrials.gov registry entry for NCT00288873 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Ergocalciferol is the first listed.
NCT00288873 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00288873 about?
NCT00288873 is a clinical study titled "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 comp...
What is the current status of trial NCT00288873?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2006-02. Estimated completion is 2007-07.
What conditions does trial NCT00288873 study?
This clinical trial studies the following conditions: Obesity, Vitamin D Deficiency, Secondary Hyperparathyroidism.
What interventions are being tested in trial NCT00288873?
The interventions under investigation include: Ergocalciferol (DRUG), Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT00288873?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00288873 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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