Assessment of Vitamin D Supplementation and Immune Function
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 20 - 49 |
| Updated: | 10/19/2013 |
| Start Date: | January 2011 |
| End Date: | December 2014 |
| Contact: | Ellen Bonnel |
| Email: | ellen.bonnel@ars.usda.gov |
| Phone: | (530) 752-4184 |
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).
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.
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
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