Assessment of Vitamin D Supplementation and Immune Function (FL-82)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01399151
First received: June 30, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Vitamin D - Treatment 1
Dietary Supplement: Vitamin D - Treatment 2
Dietary Supplement: Vitamin D - Treatment 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Assessment of Vitamin D Supplementation and Immune Function

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in Cathelicidin levels in granulocytes [ Time Frame: 0, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells [ Time Frame: 0, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum cytokines and acute phase proteins [ Time Frame: 0, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in markers of response to tetanus vaccination [ Time Frame: 0, 8, 9, 10 and 12 weeks ] [ Designated as safety issue: No ]
    Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.

  • Change in serum 25OH Vitamin D [ Time Frame: 0, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • Change in urinary calcium-to-creatinine ratio [ Time Frame: 0, 2, 4, 6, 8 and 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in level of 5-lipoxygenase protein in granulocytes [ Time Frame: 0, 8 and 12 weeks ] [ Designated as safety issue: No ]
  • Change in production of leukotrienes in granulocytes [ Time Frame: 0, 8, and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D - Treatment 1
400 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 1
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Experimental: Vitamin D- Treatment 2
2,000 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 2
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Experimental: Vitamin D- Treatment 3
5,000 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 3
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 20-49 (men) and 20-45 (women)
  • BMI 18.5-30
  • Serum 25OH Vitamin D 25-50 nmol/L

Exclusion Criteria:

  • Pregnant or nursing women
  • Daily smoker
  • Anemia (Hgb<12 mg/dL for women and <13 mg/dL for men) determined at initial visit
  • Any report or diagnosis of disease or chronic condition that may affect vitamin D absorption such as cystic fibrosis, celiac disease, surgical removal of part of the stomach or intestines, and some forms of liver disease
  • Diagnosis of hyper parathyroidism and chronic granulomatous disease, which increases risk of hypercalcemia.
  • Planned to travel to a location at which either altitude or latitude would result in significant vitamin D synthesis during the study period.
  • Not previously vaccinated with TT, or vaccinated within five years
  • Use of steroids or antibiotics within the past 4 weeks
  • Current use of nutritional supplements that may alter immune function such as omega 3 fatty acid supplements
  • Current use of anti-inflammatory or anti-convulsion medications
  • Self reported history of significant adverse response to previous vaccinations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399151

Locations
United States, California
Western Human Nutrition Center, University of California Davis
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Charles Stephensen, PhD WHNRC, ARS, University of California Davis
  More Information

Additional Information:
No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01399151     History of Changes
Other Study ID Numbers: WHNRC 213949-1, USDA CRIS 5306-51530-018-00D
Study First Received: June 30, 2011
Last Updated: October 29, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by USDA, Western Human Nutrition Research Center:
Vitamin D
Immune function

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014