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Effects of Vitamin D Insufficiency in Man

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ClinicalTrials.gov Identifier: NCT01848236
Recruitment Status : Suspended
First Posted : May 7, 2013
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
John Adams, M.D., University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE May 2, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
Change in serum 25D [ Time Frame: 5 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01848236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
  • Change in bone mineral density by biochemistry [ Time Frame: 5 weeks ]
  • Change in muscle strength by exam [ Time Frame: 5 weeks ]
  • Change in muscle strength by questionnaire [ Time Frame: 5 weeks ]
  • Change in bone mineral density by DXA scan [ Time Frame: 5 weeks ]
  • Change in fractional urinary calcium:creatinine excretion ratio [ Time Frame: 5 weeks ]
  • Change in serum 1,25D [ Time Frame: 5 weeks ]
  • Change in serum iPTH [ Time Frame: 5 weeks ]
  • Change in serum bone biomarkers [ Time Frame: 5 weeks ]
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 Effects of Vitamin D Insufficiency in Man
Official Title  ICMJE Effects of Vitamin D Insufficiency in Man
Brief Summary We would like to determine if vitamin D insufficiency exists in different ethnic groups, if it has an effect on bone mass and muscle function, if it has an impact on the function of the cells of the immune system, and if the functioning level of these systems can be improved by stabilizing the vitamin D levels to within normal limits.
Detailed Description

Vitamin D is a hormone that can either be made in the skin under the influence of sunlight or absorbed from the diet. Roughly 50% of the U.S. population suffers from an insufficiency of vitamin D and its more active metabolites. This defect can result in disorders in the bones, muscles and immune system. In humans, these disorders usually present themselves as decreased bone mass, decreased muscle strength and increased susceptibility to some infections, respectively.

Therefore, the purpose of this study is to:

  1. determine, by use of skeletal and immune biomarkers in the blood and urine, whether vitamin D insufficiency exists in differently pigmented ethnic groups; skin pigmentation blocks vitamin D production in the skin;
  2. determine whether the vitamin D status of the host has an impact on bone mass and muscle function;
  3. ascertain whether the vitamin D status of the host has an impact on the function of cells of the immune system;
  4. determine the effects of correction of vitamin insufficiency on the musculoskeletal and immune systems.

All tests are designed to gauge the state of the circulating and urine factors that contribute to overall calcium balance and/or imbalance. This will include screening for the presence or absence of active and latent infection with the agent that causes TB. If evidence of active TB is identified, one of the physician investigators in this study will inform the subject of the outcome of the screening test and this information will be reported to the California State Health Department.

Additionally, blood and related medical information will ultimately be stored in our UCLA Repository (Human Vitamin D Sample Bank) in the CTRC (Clinical Translational Research Center) in order to allow sharing of the cells with other approved researchers. The cells may be used for other future research related to the purposes described above.

We will enroll vitamin D-deficient subjects (African American, Hispanic and white) and vitamin D-sufficient matching controls against which to compare them. Deficient subjects will be randomized to receive a total of 500,000 IU of vitamin D2 or D3, at the standard replacement dose of vitamin 50,000 IU twice weekly for 5 weeks. Subjects will complete screening medical history, questionnaire, biochemical and DXA (if indicated for low bone mineral density) screening, and exam of muscle strength and/or back curvature (if indicated). Blood and urine will be collected to gauge the state of the circulating and urine factors that contribute to the subjects' overall calcium balance and/or imbalance, and to test for TB. After 5 weeks of vitamin D treatment, subjects will return for repeat testings. Subjects who are still vitamin D-deficient will undergo an additional 5-week regimen. Subjects for whom changes in bone mineral density and/or muscle strength are outcome measures will return one year later for repeat testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE
  • Dietary Supplement: Vitamin D2
    Ergocalciferol vitamin D2
  • Dietary Supplement: Vitamin D3
    Cholecalciferol vitamin D2
Study Arms  ICMJE
  • Experimental: Vitamin D2
    Total of 500,000 IU vitamin D2 (50,000 IU twice weekly for 5 weeks)
    Intervention: Dietary Supplement: Vitamin D2
  • Experimental: Vitamin D3
    Total of 500,000 IU vitamin D3 (50,000 IU twice weekly for 5 weeks)
    Intervention: Dietary Supplement: Vitamin D3
Publications * Shieh A, Chun RF, Ma C, Witzel S, Meyer B, Rafison B, Swinkels L, Huijs T, Pepkowitz S, Holmquist B, Hewison M, Adams JS. Effects of High-Dose Vitamin D2 Versus D3 on Total and Free 25-Hydroxyvitamin D and Markers of Calcium Balance. J Clin Endocrinol Metab. 2016 Aug;101(8):3070-8. doi: 10.1210/jc.2016-1871. Epub 2016 May 18.

*   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 Suspended
Estimated Enrollment  ICMJE
 (submitted: May 2, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 25D levels <30 ng/ml (Vitamin D sufficient) OR <20 ng/ml (Vitamin D deficient)
  • At least 18 years of age

Exclusion Criteria:

  • Hypercalcemia
  • Hyperparathyroidism
  • Hyperthyroidism
  • Hypercalciuria
  • Renal disease
  • Intestinal malabsorption any disorder that places the subject at risk for developing hypercalcemia or hypercalciuria during standard vitamin D replacement therapy owing to the presence of underlying dysregulated vitamin D metabolism (e.g., sarcoidosis, TB, etc)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01848236
Other Study ID Numbers  ICMJE Adams VitD 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Adams, M.D., University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John S Adams, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date October 2018

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