Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function
3 other identifiers
interventional
35
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jun 2014
Longer than P75 for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2019
CompletedApril 28, 2021
April 1, 2021
5.5 years
March 12, 2014
April 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in total serum 25D
16 weeks
Secondary Outcomes (8)
Change in serum free 25D
16 weeks
Change in serum total 1,25D
16 weeks
Change in total free 1,25D
16 weeks
Change in serum calcium
16 weeks
Change in urinary calcium
16 weeks
- +3 more secondary outcomes
Study Arms (2)
25(OH)D3
EXPERIMENTAL20 micrograms/day by mouth for 16 weeks
Vitamin D3
EXPERIMENTAL2,400 IU/day by mouth for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18
- D \< 20 mg/ml
You may not qualify if:
- Age \< 18
- D \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles, California, 90095, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Related Publications (2)
Shieh A, Lee SM, Lagishetty V, Gottleib C, Jacobs JP, Adams JS. Pilot Trial of Vitamin D3 and Calcifediol in Healthy Vitamin D Deficient Adults: Does It Change the Fecal Microbiome? J Clin Endocrinol Metab. 2021 Nov 19;106(12):3464-3476. doi: 10.1210/clinem/dgab573.
PMID: 34343292DERIVEDShieh A, Ma C, Chun RF, Wittwer-Schegg J, Swinkels L, Huijs T, Wang J, Donangelo I, Hewison M, Adams JS. Associations Between Change in Total and Free 25-Hydroxyvitamin D With 24,25-Dihydroxyvitamin D and Parathyroid Hormone. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3368-3375. doi: 10.1210/jc.2018-00515.
PMID: 29931358DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John S Adams, MD
University of California, Los Angeles Department of Orhtopaedic Surgery
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Orthopaedic Surgery
Study Record Dates
First Submitted
March 12, 2014
First Posted
March 19, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 7, 2019
Last Updated
April 28, 2021
Record last verified: 2021-04