NCT01399151

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

2.9 years

First QC Date

June 30, 2011

Last Update Submit

April 21, 2014

Conditions

Vitamin D Deficiency

Keywords

Vitamin DImmune function

Outcome Measures

Primary Outcomes (6)

  • 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 (2)

  • 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

Study Arms (3)

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

Vitamin D - Treatment 1DIETARY_SUPPLEMENT

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

Vitamin D - Treatment 1
Vitamin D - Treatment 2DIETARY_SUPPLEMENT

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

Vitamin D- Treatment 2
Vitamin D - Treatment 3DIETARY_SUPPLEMENT

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

Vitamin D- Treatment 3

Eligibility Criteria

Age20 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-49 (men) and 20-45 (women)
  • BMI 18.5-30
  • Serum 25OH Vitamin D 25-50 nmol/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

Location

Related Links

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Charles Stephensen, PhD

    WHNRC, ARS, University of California Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 21, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

US(1)