Assessment of Vitamin D Supplementation and Immune Function | NCT01399151

Studies
Assessment of Vitamin D Supplementation and Immune Function

NCT01399151

Sponsor

USDA, Western Human Nutrition Research Center

Status

Completed

Last Update Posted

Apr 22, 2014Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

Vitamin D - Treatment 1
Vitamin D - Treatment 2
Vitamin D - Treatment 3

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
USDA CRIS 5306-51530-018-00D	Other Grant/Funding Number	USDA

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jun 30, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2014

Last Update Posted Date

Apr 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D - Treatment 1	Experimental	400 IU/day Vitamin D	Dietary Supplement: Vitamin D - Treatment 1
Vitamin D- Treatment 2	Experimental	2,000 IU/day Vitamin D	Dietary Supplement: Vitamin D - Treatment 2
Vitamin D- Treatment 3	Experimental	5,000 IU/day Vitamin D	Dietary Supplement: Vitamin D - Treatment 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D - Treatment 1	Dietary Supplement	Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.	Vitamin D - Treatment 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Cathelicidin levels in granulocytes		0, 8, and 12 weeks
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells		0, 8 and 12 weeks
Change in serum cytokines and acute phase proteins		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.	0, 8, 9, 10 and 12 weeks
Change in serum 25OH Vitamin D		0, 4, 8, and 12 weeks
Change in urinary calcium-to-creatinine ratio		0, 2, 4, 6, 8 and 10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in level of 5-lipoxygenase protein in granulocytes		0, 8 and 12 weeks
Change in production of leukotrienes in granulocytes		0, 8, and 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Stephensen, PhD	WHNRC, ARS, University of California Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Human Nutrition Center, University of California Davis		Davis	California	95616	United States

Label	URL
USDA Western Human Nutrition Research Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided