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

Vitamin D Deficiency Clinical Trial

Official title:

The Effects of Vitamin D3 Versus 25OHD3 (HyD) on Serum Vitamin D Metabolites and Markers of Mineral Metabolism and Immune Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091219
• Other study ID #: UL1TR000124-1954
• Secondary ID: 1P50AR063020-01U
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2014
• Est. completion date: December 7, 2019

Study information

• Verified date: April 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 7, 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
2400 IU/day by mouth for 16 weeks
• 25(OH)D3
20 micrograms/day by mouth for 16 weeks

Locations

Country	Name	City	State
United States	UCLA Clinical and Translational Research Center (CTRC)	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total serum 25D		16 weeks
Secondary	Change in serum free 25D		16 weeks
Secondary	Change in serum total 1,25D		16 weeks
Secondary	Change in total free 1,25D		16 weeks
Secondary	Change in serum calcium		16 weeks
Secondary	Change in urinary calcium		16 weeks
Secondary	Change in serum iPTH		16 weeks
Secondary	Change in serum bone turnover markers		16 weeks
Secondary	Change in markers of immune function		16 weeks