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OpenTrials
Completed

NCT Number: NCT01399151

Assessment of Vitamin D Supplementation and Immune Function

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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Key information

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D - Treatment 1

Dietary Supplement

Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.

Vitamin D - Treatment 2

Dietary Supplement

Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.

Vitamin D - Treatment 3

Dietary Supplement

Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.

Primary outcomes

  1. Change in Cathelicidin levels in granulocytes

    Time frame: 0, 8, and 12 weeks

  2. Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells

    Time frame: 0, 8 and 12 weeks

  3. Change in serum cytokines and acute phase proteins

    Time frame: 0, 8 and 12 weeks

  4. Change in markers of response to tetanus vaccination

    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.

  5. Change in serum 25OH Vitamin D

    Time frame: 0, 4, 8, and 12 weeks

  6. Change in urinary calcium-to-creatinine ratio

    Time frame: 0, 2, 4, 6, 8 and 10 weeks

Secondary outcomes

  1. Change in level of 5-lipoxygenase protein in granulocytes

    Time frame: 0, 8 and 12 weeks

  2. Change in production of leukotrienes in granulocytes

    Time frame: 0, 8, and 12 weeks

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Acronym: FL-82

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 21, 2011
Registry last updated
Apr 22, 2014

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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