Assessment of Vitamin D Supplementation and Immune Function
- Conditions
- Vitamin D Deficiency
- Interventions
- Dietary Supplement: Vitamin D - Treatment 1Dietary Supplement: Vitamin D - Treatment 2Dietary Supplement: Vitamin D - Treatment 3
- Registration Number
- NCT01399151
- Lead Sponsor
- USDA, Western Human Nutrition Research Center
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Age 20-49 (men) and 20-45 (women)
- BMI 18.5-30
- Serum 25OH Vitamin D 25-50 nmol/L
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D - Treatment 1 Vitamin D - Treatment 1 400 IU/day Vitamin D Vitamin D- Treatment 2 Vitamin D - Treatment 2 2,000 IU/day Vitamin D Vitamin D- Treatment 3 Vitamin D - Treatment 3 5,000 IU/day Vitamin D
- Primary Outcome Measures
Name Time Method Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells 0, 8 and 12 weeks Change in Cathelicidin levels in granulocytes 0, 8, and 12 weeks Change in serum cytokines and acute phase proteins 0, 8 and 12 weeks Change in serum 25OH Vitamin D 0, 4, 8, and 12 weeks Change in markers of response to tetanus vaccination 0, 8, 9, 10 and 12 weeks Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.
Change in urinary calcium-to-creatinine ratio 0, 2, 4, 6, 8 and 10 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Western Human Nutrition Center, University of California Davis
🇺🇸Davis, California, United States