Assessment of Vitamin D Supplementation and Immune Function
NCT ID: NCT01399151
Last Updated: 2014-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2011-01-31
2014-04-30
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Vitamin D - Treatment 1
400 IU/day Vitamin D
Vitamin D - Treatment 1
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Vitamin D- Treatment 2
2,000 IU/day Vitamin D
Vitamin D - Treatment 2
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Vitamin D- Treatment 3
5,000 IU/day Vitamin D
Vitamin D - Treatment 3
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
Interventions
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Vitamin D - Treatment 1
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Vitamin D - Treatment 2
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Vitamin D - Treatment 3
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* BMI 18.5-30
* Serum 25OH Vitamin D 25-50 nmol/L
Exclusion Criteria
* 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
20 Years
49 Years
ALL
Yes
Sponsors
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USDA, Western Human Nutrition Research Center
FED
Responsible Party
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Principal Investigators
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Charles Stephensen, PhD
Role: PRINCIPAL_INVESTIGATOR
WHNRC, ARS, University of California Davis
Locations
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Western Human Nutrition Center, University of California Davis
Davis, California, United States
Countries
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Related Links
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USDA Western Human Nutrition Research Center
Other Identifiers
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USDA CRIS 5306-51530-018-00D
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WHNRC 213949-1
Identifier Type: -
Identifier Source: org_study_id
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