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Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function

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ClinicalTrials.gov Identifier: NCT02091219
Recruitment Status : Unknown
Verified October 2018 by John Adams, M.D., University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : March 19, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
John Adams, M.D., University of California, Los Angeles

Brief Summary:
The purpose of this study is to compare the effects of two different forms of vitamin D supplements (vitamin D3 and 25-hyrdroxyvitamin D3 [25(OH)D3]) on vitamin D levels in the blood, and on markers of skeletal and immune health. This study is designed as a pilot study. A multi-ethnic cohort of 48 patients will be included (12 Caucasian, 12 African American, 12 Hispanic/Latino, 12 Asian/Asian American). Potential study candidates will undergo a screening visit during which a medical history will be taken, a physical exam performed, a dietary questionnaire administered, and blood collected. The purpose of the screening visit is to identify vitamin D-deficient (25-hydroxyvitamin D <20 ng/ml) individuals who are candidates for vitamin D supplementation. Eligible patients will then be randomly assigned to receive either vitamin D3 (2400 IU/day) or 25(OH)D3 (20 mcg/day) for 16 weeks. After initiating supplementation, study patients will return for follow-up visits at weeks 4, 8, and 16. At each visit, blood will be collected to assess vitamin D levels in the blood, as well as markers of skeletal and immune function. Participation in this study will therefore involve a total of 5 visits (1 screening visit, 1 randomization visit during which participants will receive their study supplements, 3 follow-up visits). After all data is collected, changes in vitamin D levels in the blood following supplementation with either vitamin D3 versus 25(OH)D3 will be determined, and correlated to markers of calcium balance and immune function. Knowledge gained from this study may have a significant impact on how vitamin D status is defined, and how vitamin D repletion is administered.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D Drug: 25(OH)D3 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: 25(OH)D3
20 micrograms/day by mouth for 16 weeks
Drug: 25(OH)D3
20 micrograms/day by mouth for 16 weeks
Other Names:
  • Calcifediol
  • HyD

Experimental: Vitamin D3
2,400 IU/day by mouth for 16 weeks
Drug: Vitamin D
2400 IU/day by mouth for 16 weeks
Other Name: Cholecalciferol




Primary Outcome Measures :
  1. Change in total serum 25D [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in serum free 25D [ Time Frame: 16 weeks ]
  2. Change in serum total 1,25D [ Time Frame: 16 weeks ]
  3. Change in total free 1,25D [ Time Frame: 16 weeks ]
  4. Change in serum calcium [ Time Frame: 16 weeks ]
  5. Change in urinary calcium [ Time Frame: 16 weeks ]
  6. Change in serum iPTH [ Time Frame: 16 weeks ]
  7. Change in serum bone turnover markers [ Time Frame: 16 weeks ]
  8. Change in markers of immune function [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • 25D < 20 mg/ml

Exclusion Criteria:

  • Age < 18
  • 25D > 20 ng/ml at time of screening
  • Clear signs of infection at time of screening (coughing, sneezing, wheezing, frequency, dysuria)
  • History of conditions that would influence intestinal absorption of vitamin D3 or 25OHD3 supplements
  • History of nephrolithiasis, primary hyperparathyroidism, or other metabolic bone disease
  • History of chronic kidney disease (defined as CrCl < 30 ml/min)
  • History of rheumatologic or autoimmune conditions
  • History of sarcoidosis
  • History of active or latent tuberculosis
  • History of HIV
  • History of hyperthyroidism
  • History of chronic glucocorticoid use defined as the equivalent of 5 mg of prednisone per day for more than 2 months within the last 6 months
  • History of use of medications known to affect calcium/vitamin D metabolism, bone metabolism, and immune response
  • Hypercalcemia
  • Hypercalcinuria

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 ClinicalTrials.gov identifier (NCT number): NCT02091219


Contacts
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Contact: John S Adams, MD (310) 825-5585 jsadams@mednet.ucla.edu
Contact: Albert Shieh, MD (424) 248-5617 ashieh@mednet.ucla.edu

Locations
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United States, California
UCLA Clinical and Translational Research Center (CTRC) Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Albert Shieh, MD    424-248-5617    ashieh@mednet.ucla.edu   
Contact: Gloria Kiel    (310) 825-1394    gskiel@mednet.ucla.edu   
Principal Investigator: John S Adams, MD         
Sub-Investigator: Albert Shieh, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: John S Adams, MD University of California, Los Angeles Department of Orhtopaedic Surgery
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Adams, M.D., Professor, Department of Orthopaedic Surgery, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02091219    
Other Study ID Numbers: UL1TR000124-1954
1P50AR063020-01 ( U.S. NIH Grant/Contract )
UL1TR000124 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by John Adams, M.D., University of California, Los Angeles:
Hypovitaminosis D
Free 25-hydroxyvitamin D
Total 25-hydroxyvitamin D
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents