Vitamin D DeficiencyFL-82NCT01399151
Assessment of Vitamin D Supplementation and Immune Function
A study testing Vitamin D - Treatment 1, Vitamin D - Treatment 2 and Vitamin D - Treatment 3 in people with Vitamin D Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D - Treatment 1, Vitamin D - Treatment 2 and Vitamin D - Treatment 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-49 (men) and 20-45 (women)
- BMI 18.5-30
- Serum 25OH Vitamin D 25-50 nmol/L
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Center, University of California Davis
Davis, California, 95616
About this study
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).
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D - Treatment 1, Vitamin D - Treatment 2, Vitamin D - Treatment 3
- Keywords
- Vitamin D, Immune function
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D - Treatment 1Dietary supplement
Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
Vitamin D - Treatment 2Dietary supplement
Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
Vitamin D - Treatment 3Dietary supplement
Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D - Treatment 1 | Experimental | 400 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D - Treatment 1 |
| Vitamin D- Treatment 2 | Experimental | 2,000 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D - Treatment 2 |
| Vitamin D- Treatment 3 | Experimental | 5,000 IU/day Vitamin D Receives: Dietary Supplement: Vitamin D - Treatment 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cathelicidin levels in granulocytes
Measured: 0, 8, and 12 weeks
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells
Measured: 0, 8 and 12 weeks
Change in serum cytokines and acute phase proteins
Measured: 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.
Measured: 0, 8, 9, 10 and 12 weeks
Change in serum 25OH Vitamin D
Measured: 0, 4, 8, and 12 weeks
Change in urinary calcium-to-creatinine ratio
Measured: 0, 2, 4, 6, 8 and 10 weeks
Secondary outcomes (2)
Change in level of 5-lipoxygenase protein in granulocytes
Measured: 0, 8 and 12 weeks
Change in production of leukotrienes in granulocytes
Measured: 0, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Charles Stephensen, PhD, Principal investigator, WHNRC, ARS, University of California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399151
- Sponsor's protocol ID
- WHNRC 213949-1
- Other IDs
- USDA CRIS 5306-51530-018-00D
- Acronym
- FL-82
- Status last verified
- Apr 2014
- First submitted
- 30 Jun 2011
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vitamin D Supplementation and Immune Function
- ClinicalTrials.gov ID
- NCT01399151
- Acronym / sponsor ID
- FL-82 / WHNRC 213949-1
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D - Treatment 1 | Experimental | Dietary Supplement: Vitamin D - Treatment 1400 IU/day Vitamin D |
| Vitamin D- Treatment 2 | Experimental | Dietary Supplement: Vitamin D - Treatment 22,000 IU/day Vitamin D |
| Vitamin D- Treatment 3 | Experimental | Dietary Supplement: Vitamin D - Treatment 35,000 IU/day Vitamin D |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-49 (men) and 20-45 (women)
- BMI 18.5-30
- Serum 25OH Vitamin D 25-50 nmol/L
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D - Treatment 1Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks. | Dietary supplement | Vitamin D - Treatment 1 |
| Vitamin D - Treatment 2Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks. | Dietary supplement | Vitamin D- Treatment 2 |
| Vitamin D - Treatment 3Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks. | Dietary supplement | Vitamin D- Treatment 3 |
Primary outcome
Change in Cathelicidin levels in granulocytes
Time frame: 0, 8, and 12 weeks
Change in cytokine levels from stimulated Periferal Blood Mononuclear Cells
Time frame: 0, 8 and 12 weeks
Change in serum cytokines and acute phase proteins
Time frame: 0, 8 and 12 weeks
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.
Change in serum 25OH Vitamin D
Time frame: 0, 4, 8, and 12 weeks
Change in urinary calcium-to-creatinine ratio
Time frame: 0, 2, 4, 6, 8 and 10 weeks
2 secondary outcomes
Change in level of 5-lipoxygenase protein in granulocytes
Time frame: 0, 8 and 12 weeks
Change in production of leukotrienes in granulocytes
Time frame: 0, 8, and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Stephensen, PhD principal investigator
WHNRC, ARS, University of California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D - Treatment 1, Vitamin D - Treatment 2 and Vitamin D - Treatment 3 in people with Vitamin D Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cathelicidin levels in granulocytes (time frame: 0, 8, and 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2014.