Assessment of Vitamin D Supplementation and Immune Function

Vitamin D Deficiency Clinical Trial

— FL-82  

Official title:

Assessment of Vitamin D Supplementation and Immune Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399151
• Other study ID #: WHNRC 213949-1
• Secondary ID: USDA CRIS 5306-5
• Status: Completed
• Phase: N/A
• First received: June 30, 2011
• Last updated: April 21, 2014
• Start date: January 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D - Treatment 1
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
• Vitamin D - Treatment 2
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
• Vitamin D - Treatment 3
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.

Locations

Country	Name	City	State
United States	Western Human Nutrition Center, University of California Davis	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cathelicidin levels in granulocytes		0, 8, and 12 weeks	No
Primary	Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells		0, 8 and 12 weeks	No
Primary	Change in serum cytokines and acute phase proteins		0, 8 and 12 weeks	No
Primary	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.	0, 8, 9, 10 and 12 weeks	No
Primary	Change in serum 25OH Vitamin D		0, 4, 8, and 12 weeks	No
Primary	Change in urinary calcium-to-creatinine ratio		0, 2, 4, 6, 8 and 10 weeks	Yes
Secondary	Change in level of 5-lipoxygenase protein in granulocytes		0, 8 and 12 weeks	No
Secondary	Change in production of leukotrienes in granulocytes		0, 8, and 12 weeks	No

External Links

•   USDA Western Human Nutrition Research Center