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

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT02091219

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

Enrollment

Locations

Arms

66.2

Duration (Months)

17.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual 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 :

Jun 1, 2014

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 7, 2019

Arms and Interventions

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 Names: Cholecalciferol

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 Names:

Cholecalciferol

Outcome Measures

Primary Outcome Measures

Change in total serum 25D [16 weeks]

Secondary Outcome Measures

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]
Change in serum iPTH [16 weeks]
Change in serum bone turnover markers [16 weeks]
Change in markers of immune function [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Clinical and Translational Research Center (CTRC)	Los Angeles	California	United States	90095
2	University of California, Los Angeles	Los Angeles	California	United States	90095