Back to resultsAssessment of Vitamin D Supplementation and Immune Function (FL-82)
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D - Treatment 1
Vitamin D - Treatment 2
Vitamin D - Treatment 3
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin D Deficiency focused on measuring Vitamin D, Immune function
Eligibility Criteria
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
Sites / Locations
- Western Human Nutrition Center, University of California Davis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Vitamin D - Treatment 1
Vitamin D- Treatment 2
Vitamin D- Treatment 3
Arm Description
400 IU/day Vitamin D
2,000 IU/day Vitamin D
5,000 IU/day Vitamin D
Outcomes
Primary Outcome Measures
Change in Cathelicidin levels in granulocytes
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells
Change in serum cytokines and acute phase proteins
Change in markers of response to tetanus vaccination
Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.
Change in serum 25OH Vitamin D
Change in urinary calcium-to-creatinine ratio
Secondary Outcome Measures
Change in level of 5-lipoxygenase protein in granulocytes
Change in production of leukotrienes in granulocytes
Full Information
NCT ID
NCT01399151
First Posted
June 30, 2011
Last Updated
April 21, 2014
Sponsor
USDA, Western Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01399151
Brief Title
Assessment of Vitamin D Supplementation and Immune Function
Acronym
FL-82
Official Title
Assessment of Vitamin D Supplementation and Immune Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Immune function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D - Treatment 1
Arm Type
Experimental
Arm Description
400 IU/day Vitamin D
Arm Title
Vitamin D- Treatment 2
Arm Type
Experimental
Arm Description
2,000 IU/day Vitamin D
Arm Title
Vitamin D- Treatment 3
Arm Type
Experimental
Arm Description
5,000 IU/day Vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D - Treatment 1
Intervention Description
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D - Treatment 2
Intervention Description
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D - Treatment 3
Intervention Description
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
Primary Outcome Measure Information:
Title
Change in Cathelicidin levels in granulocytes
Time Frame
0, 8, and 12 weeks
Title
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells
Time Frame
0, 8 and 12 weeks
Title
Change in serum cytokines and acute phase proteins
Time Frame
0, 8 and 12 weeks
Title
Change in markers of response to tetanus vaccination
Description
Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.
Time Frame
0, 8, 9, 10 and 12 weeks
Title
Change in serum 25OH Vitamin D
Time Frame
0, 4, 8, and 12 weeks
Title
Change in urinary calcium-to-creatinine ratio
Time Frame
0, 2, 4, 6, 8 and 10 weeks
Secondary Outcome Measure Information:
Title
Change in level of 5-lipoxygenase protein in granulocytes
Time Frame
0, 8 and 12 weeks
Title
Change in production of leukotrienes in granulocytes
Time Frame
0, 8, and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Stephensen, PhD
Organizational Affiliation
WHNRC, ARS, University of California Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Human Nutrition Center, University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ars.usda.gov/Main/docs.htm?docid=11240
Description
USDA Western Human Nutrition Research Center
Learn more about this trial
Assessment of Vitamin D Supplementation and Immune Function
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