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Assessment of Vitamin D Supplementation and Immune Function

NCT01399151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-04-22

No results posted yet for this study

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).

Conditions

  • Vitamin D Deficiency

Interventions

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.

Sponsors & Collaborators

  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Charles Stephensen, PhD · WHNRC, ARS, University of California Davis

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399151 on ClinicalTrials.gov