Assessment of Vitamin D Supplementation and Immune Function (FL-82)

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D - Treatment 3; Dietary Supplement: Vitamin D - Treatment 2; Dietary Supplement: Vitamin D - Treatment 1

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01399151

WHNRC 213949-1

USDA CRIS 5306-51530-018-00D (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 3 patient groups

Vitamin D - Treatment 1

Experimental group

Description:

400 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D - Treatment 1

Vitamin D- Treatment 2

Experimental group

Description:

2,000 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D - Treatment 2

Vitamin D- Treatment 3

Experimental group

Description:

5,000 IU/day Vitamin D

Treatment:

Dietary Supplement: Vitamin D - Treatment 3