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The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

28. juli 2011 opdateret af: Tehran University of Medical Sciences

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Iran, Islamisk Republik
      • Tehran, Iran, Islamisk Republik
        • Tehran University of Medical Sciences, School of Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 52 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Non obese/ vitamin A
Non obese individuals with body mass index 18.5-24.9 kg/m2 who receive 25000 IU/day vitamin A for 4 months .
Kosttilskud: Vitamin A

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month
Placebo komparator: obese/ placebo
obese individuals with body mass index greator than 30 kg/m2 who receive 1 cap placebo per day for 4 months .
Kosttilskud: Vitamin A

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month
Aktiv komparator: Obese/ vitamin A
obese individuals with body mass index greater than 30 kg/m2 who receive 25000 IU/day vitamin A for 4 months
Kosttilskud: Vitamin A

25000 IU/day vitamin A 4 months

1 Cap/Day

1 cap placebo/day for 4 month

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Complete Blood Count-diff
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum HDL concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum LDL concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum total cholesterol concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum Triglycerides concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum SGOT concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum SGPT concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum T3 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum T4 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum TSH concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum FBS concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum CRP concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum RF concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months

Sekundære resultatmål

Resultatmål
Tidsramme
Serum IL-2 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-6 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-10 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-12 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-13 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum IL-17 concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Seum IL-1β concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
Serum TGF β concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
serum IFN γ concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months
serum Angiotensin П concentrations
Tidsramme: Change from baseline at 4 months
Change from baseline at 4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tehran University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Forventet)

1. februar 2013

Studieafslutning (Forventet)

1. august 2013

Datoer for studieregistrering

Først indsendt

14. februar 2011

Først indsendt, der opfyldte QC-kriterier

28. juli 2011

Først opslået (Skøn)

29. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 89-04-27-11869

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Vitamin A

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Betingelser

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Kosttilskud

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Placeringer

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