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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01399151
First received: June 30, 2011
Last updated: April 21, 2014
Last verified: April 2014
  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 ]

Enrollment: 23
Study Start Date: January 2011
Study Completion Date: April 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 21, 2014
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
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014