NCT01399151

Assessment of Vitamin D Supplementation and Immune Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: USDA, Western Human Nutrition Research Center · Federal
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Hypothesis: Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose vitamin D supplements (400 IU per day).

Detailed description

Specific Aim 1: Determine if high dose vitamin D supplements decrease the production of proinflammatory and increase the production of regulatory cytokines and chemokines by innate immune cells stimulated ex vivo. Specific Aim 2: Determine if high dose vitamin D supplements decrease serum markers of inflammation and increase serum and cellular levels of defensive molecules (e.g., cathelicidin). Specific Aim 3: Determine if high dose vitamin D supplements decrease blood levels of proinflammatory T-helper type 1 (Th1) and Th17 cells and increase levels of anti-inflammatory T-regulatory (Treg) and Th2 cells. Specific Aim 4: Determine if high dose vitamin D supplements increase antigen specific T cell and B cell responses after tetanus vaccination.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D - Treatment 1	Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
DIETARY_SUPPLEMENT	Vitamin D - Treatment 2	Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
DIETARY_SUPPLEMENT	Vitamin D - Treatment 3	Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-01
• Completion: 2014-04-01
• First posted: 2011-07-21
• Last updated: 2014-04-22

Locations

1 site across 1 country: United States