Western Human Nutrition Center, University of California Davis
Davis, California, 95616, United States
NCT Number: NCT01399151
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).
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Notify Me20 year–49 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 0, 8, and 12 weeks
Time frame: 0, 8 and 12 weeks
Time frame: 0, 8 and 12 weeks
Time frame: 0, 8, 9, 10 and 12 weeks
Markers of response to tetanus vaccine include tetanus-specific proliferation and production of cytokines by CD4 T-helper cells.
Time frame: 0, 4, 8, and 12 weeks
Time frame: 0, 2, 4, 6, 8 and 10 weeks
Time frame: 0, 8 and 12 weeks
Time frame: 0, 8, and 12 weeks
USDA, Western Human Nutrition Research Center
Fed
Acronym: FL-82
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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