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

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).

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D - Treatment 1; Dietary supplement: Vitamin D - Treatment 2; Dietary supplement: Vitamin D - Treatment 3

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Western Human Nutrition Center, University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cathelicidin levels in granulocytes		0, 8, and 12 weeks
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells		0, 8 and 12 weeks
Change in serum cytokines and acute phase proteins		0, 8 and 12 weeks
Change in markers of response to tetanus vaccination	Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.	0, 8, 9, 10 and 12 weeks
Change in serum 25OH Vitamin D		0, 4, 8, and 12 weeks
Change in urinary calcium-to-creatinine ratio		0, 2, 4, 6, 8 and 10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in level of 5-lipoxygenase protein in granulocytes	0, 8 and 12 weeks
Change in production of leukotrienes in granulocytes	0, 8, and 12 weeks

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Investigators: Principal Investigator: Charles Stephensen, PhD, WHNRC, ARS, University of California Davis

Publications and helpful links

Helpful Links

• USDA Western Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 21, 2011

Study Record Updates

• Last Update Posted (Estimate): April 22, 2014
• Last Update Submitted That Met QC Criteria: April 21, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Vitamin D; Immune function
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: WHNRC 213949-1; USDA CRIS 5306-51530-018-00D (Other Grant/Funding Number: USDA)