ObesityPhase 4NCT01405352
The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity
A Phase 4 study testing Vitamin A in people with Obesity, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group. Read more about this study
- Who is it for?
- Ages 20 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to Aug 2013
- Phase
- Phase 4
- 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 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- waist to hip ratio >0.8 and BMI>30 kg/m2 for obese individuals waist to hip ratio <0.8 and BMI 18.5 - 24.9 kg/m2 for Non obese individuals
Who cannot join
- subjects who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
- subjects with pregnancy, lactation, menopause, diabetes
- subjects who have allergy to vitamin A compounds, OR
- subjects who have used vitamin supplements or in last 3 months, OR
- subjects with morbid obesity(BMI >40 kg/m2),OR
- overweight subjects (25 <BMI<29.9 kg/m2)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences, School of Public Health
Tehran, Tehran Province
About this study
Official title: The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals
In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group.
Read the detailed description
Obesity is a chronic disease consisting of the increase in body fat stores. Obesity is an important health concern because of its well known relationships with metabolic and endocrine disorders such as cardiovascular disease, type 2 diabetes, hypertension and immune dysfunction. Low-grade systemic inflammation, confirmed by the increase of inflammatory markers such as C-reactive protein and interleukin-6 has been observed in obesity. CD4+ T-helpers are the most important regulators of immune system. Epidemiological evidence has linked obesity to several (but not all) autoimmune disorders, including inflammatory bowel disease (IBD) and psoriasis .Some sublineages of T- helpers plays core roles in immune dysfunction, and recent evidence demonstrates that an imbalance of T-cell subgroups including Th1, Th2, Th17 and Treg has occurred in obesity. This imbalance is the redirection of the immune response from most often Th2 and Treg like responses to Th1 and Th17 like responses respectively, however the opposite is desired. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL-12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ and TNF α production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production.
- Conditions
- Obesity
- Being tested
- Vitamin A
- Keywords
- obesity, vitamin A, immune system
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
25000 IU/day vitamin A 4 months
1 Cap/Day
1 cap placebo/day for 4 month
| Study group | Role | What they receive |
|---|---|---|
| Non obese/ vitamin A | Active comparator | Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months . Receives: Dietary Supplement: Vitamin A |
| obese/ placebo | Placebo comparator | obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months . Receives: Dietary Supplement: Vitamin A |
| Obese/ vitamin A | Active comparator | obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months Receives: Dietary Supplement: Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Blood Count-diff
Measured: Change from baseline at 4 months
Serum HDL concentrations
Measured: Change from baseline at 4 months
Serum LDL concentrations
Measured: Change from baseline at 4 months
Serum total cholesterol concentrations
Measured: Change from baseline at 4 months
Serum Triglycerides concentrations
Measured: Change from baseline at 4 months
Serum SGOT concentrations
Measured: Change from baseline at 4 months
Serum SGPT concentrations
Measured: Change from baseline at 4 months
Serum T3 concentrations
Measured: Change from baseline at 4 months
Serum T4 concentrations
Measured: Change from baseline at 4 months
Serum TSH concentrations
Measured: Change from baseline at 4 months
Serum FBS concentrations
Measured: Change from baseline at 4 months
Serum CRP concentrations
Measured: Change from baseline at 4 months
Serum RF concentrations
Measured: Change from baseline at 4 months
Secondary outcomes (10)
Serum IL-2 concentrations
Measured: Change from baseline at 4 months
Serum IL-6 concentrations
Measured: Change from baseline at 4 months
Serum IL-10 concentrations
Measured: Change from baseline at 4 months
Serum IL-12 concentrations
Measured: Change from baseline at 4 months
Serum IL-13 concentrations
Measured: Change from baseline at 4 months
Serum IL-17 concentrations
Measured: Change from baseline at 4 months
Seum IL-1β concentrations
Measured: Change from baseline at 4 months
Serum TGF β concentrations
Measured: Change from baseline at 4 months
serum IFN γ concentrations
Measured: Change from baseline at 4 months
serum Angiotensin П concentrations
Measured: Change from baseline at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405352
- Sponsor's protocol ID
- 89-04-27-11869
- Status last verified
- Jul 2011
- First submitted
- 14 Feb 2011
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin A Supplementation on CD4+ T-cell Secretion in Obese Individuals
- ClinicalTrials.gov ID
- NCT01405352
- Acronym / sponsor ID
- 89-04-27-11869
- Conditions
- Obesity
- Keywords
- obesity, vitamin A, immune system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 29 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.
In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group.
Detailed description
Obesity is a chronic disease consisting of the increase in body fat stores. Obesity is an important health concern because of its well known relationships with metabolic and endocrine disorders such as cardiovascular disease, type 2 diabetes, hypertension and immune dysfunction. Low-grade systemic inflammation, confirmed by the increase of inflammatory markers such as C-reactive protein and interleukin-6 has been observed in obesity. CD4+ T-helpers are the most important regulators of immune system. Epidemiological evidence has linked obesity to several (but not all) autoimmune disorders, including inflammatory bowel disease (IBD) and psoriasis .Some sublineages of T- helpers plays core roles in immune dysfunction, and recent evidence demonstrates that an imbalance of T-cell subgroups including Th1, Th2, Th17 and Treg has occurred in obesity. This imbalance is the redirection of the immune response from most often Th2 and Treg like responses to Th1 and Th17 like responses respectively, however the opposite is desired. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL-12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ and TNF α production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non obese/ vitamin A | Active comparator | Dietary Supplement: Vitamin ANon obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months . |
| obese/ placebo | Placebo comparator | Dietary Supplement: Vitamin Aobese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months . |
| Obese/ vitamin A | Active comparator | Dietary Supplement: Vitamin Aobese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months |
Who may qualify
- Ages
- 20 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- waist to hip ratio >0.8 and BMI>30 kg/m2 for obese individuals waist to hip ratio <0.8 and BMI 18.5 - 24.9 kg/m2 for Non obese individuals
Key exclusion criteria (6 listed)
- subjects who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
- subjects with pregnancy, lactation, menopause, diabetes
- subjects who have allergy to vitamin A compounds, OR
- subjects who have used vitamin supplements or in last 3 months, OR
- subjects with morbid obesity(BMI >40 kg/m2),OR
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 A25000 IU/day vitamin A 4 months 1 Cap/Day 1 cap placebo/day for 4 month | Dietary supplement | Non obese/ vitamin A, Obese/ vitamin A, obese/ placebo |
Primary outcome
Complete Blood Count-diff
Time frame: Change from baseline at 4 months
Serum HDL concentrations
Time frame: Change from baseline at 4 months
Serum LDL concentrations
Time frame: Change from baseline at 4 months
Serum total cholesterol concentrations
Time frame: Change from baseline at 4 months
Serum Triglycerides concentrations
Time frame: Change from baseline at 4 months
Serum SGOT concentrations
Time frame: Change from baseline at 4 months
Serum SGPT concentrations
Time frame: Change from baseline at 4 months
Serum T3 concentrations
Time frame: Change from baseline at 4 months
Serum T4 concentrations
Time frame: Change from baseline at 4 months
Serum TSH concentrations
Time frame: Change from baseline at 4 months
Serum FBS concentrations
Time frame: Change from baseline at 4 months
Serum CRP concentrations
Time frame: Change from baseline at 4 months
Serum RF concentrations
Time frame: Change from baseline at 4 months
10 secondary outcomes
Serum IL-2 concentrations
Time frame: Change from baseline at 4 months
Serum IL-6 concentrations
Time frame: Change from baseline at 4 months
Serum IL-10 concentrations
Time frame: Change from baseline at 4 months
Serum IL-12 concentrations
Time frame: Change from baseline at 4 months
Serum IL-13 concentrations
Time frame: Change from baseline at 4 months
Serum IL-17 concentrations
Time frame: Change from baseline at 4 months
Seum IL-1β concentrations
Time frame: Change from baseline at 4 months
Serum TGF β concentrations
Time frame: Change from baseline at 4 months
serum IFN γ concentrations
Time frame: Change from baseline at 4 months
serum Angiotensin П concentrations
Time frame: Change from baseline at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin A in people with Obesity, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jul 2011. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Complete Blood Count-diff (time frame: Change from baseline at 4 months). The study lists 13 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 29 Jul 2011.