Assessment of Vitamin D Supplementation and Immune Function
Completed · Not applicable
Conditions studied: Vitamin D Deficiency
In brief
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).
Key facts
- Study ID
- NCT01399151
- Run by
- USDA, Western Human Nutrition Research Center
- People needed
- 23
- Starts
- 2011-01-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2014-04-22
Who can join
Age: 20 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 20-49 (men) and 20-45 (women)
- BMI 18.5-30
- Serum 25OH Vitamin D 25-50 nmol/L
You may not qualify if…
- 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
Where it is running
- Western Human Nutrition Center, University of California Davis — Davis, California, United States
Full record on ClinicalTrials.gov
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