Status:
COMPLETED
Assessment of Vitamin D Supplementation and Immune Function
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
20-49 years
Phase:
NA
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 an...
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 stimu...
Eligibility Criteria
Inclusion
- Age 20-49 (men) and 20-45 (women)
- BMI 18.5-30
- Serum 25OH Vitamin D 25-50 nmol/L
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01399151
Start Date
January 1 2011
End Date
April 1 2014
Last Update
April 22 2014
Active Locations (1)
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1
Western Human Nutrition Center, University of California Davis
Davis, California, United States, 95616