An interventional study of Vitamin D - Treatment 1 and Vitamin D - Treatment 2 in Vitamin D Deficiency, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-22.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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.
784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 23 is below the median of 77 across 574 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
400 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 1
2,000 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 2
5,000 IU/day Vitamin D
Dietary Supplement: Vitamin D - Treatment 3
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
Change in Cathelicidin levels in granulocytes
Time frame: 0, 8, and 12 weeks
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells
Time frame: 0, 8 and 12 weeks
Change in serum cytokines and acute phase proteins
Time frame: 0, 8 and 12 weeks
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.
Time frame: 0, 8, 9, 10 and 12 weeks
Change in serum 25OH Vitamin D
Time frame: 0, 4, 8, and 12 weeks
Change in urinary calcium-to-creatinine ratio
Time frame: 0, 2, 4, 6, 8 and 10 weeks
Change in level of 5-lipoxygenase protein in granulocytes
Time frame: 0, 8 and 12 weeks
Change in production of leukotrienes in granulocytes
Time frame: 0, 8, and 12 weeks
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center