Assessment of Vitamin D Supplementation and Immune Function — FL-82  

Vitamin D Deficiency Clinical Trial

Official title: Assessment of Vitamin D Supplementation and Immune Function

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

• NCT number: NCT01399151
• Study type: Interventional
• Source: USDA, Western Human Nutrition Research Center
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Completion date: April 2014