NCT01407211

Brief Summary

The aim of this study is the comparison between the effects of supplementation with vitamin A (retinyl palmitate) or placebo for 6 months on gene expression of T CD4+ lymphocyte in multiple sclerotic patient.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

February 14, 2011

Last Update Submit

July 17, 2012

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

multiple sclerosisMyelin Oligodendrocyte Glycoprotein(MOG)Vitamin ACD4-Positive T-Lymphocytesgene expressionTh1 CellsTh2 Cells

Outcome Measures

Primary Outcomes (8)

  • serum Total cholesterol

    Change from baseline at 6 months

  • serum HDL cholesterol

    Change from baseline at 6 months

  • serum triglycerides level

    Change from baseline at 6 months

  • RBP/ TTR ratio

    Change from baseline at 6 months

  • PBMC's prolifration(BrdU colorimetric)

    Change from baseline at 6 months

  • complete blood count (CBC)

    Change from baseline at 6 months

  • serum SGOT concentration

    Change from baseline at 6 months

  • serum SGPT concentration

    Change from baseline at 6 months

Secondary Outcomes (1)

  • gene expression of T-bet, INF-gamma, IL-4, GATA3, IL-17, RORc, IL-10, FOXP3 (Relative quantification)

    Change from baseline at 6 months

Study Arms (2)

with Multiple Sclerosis/ vitamin A

ACTIVE COMPARATOR

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A

Dietary Supplement: vitamin A

with Multiple Sclerosis/ placebo

PLACEBO COMPARATOR

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day

Dietary Supplement: vitamin A

Interventions

vitamin ADIETARY_SUPPLEMENT

25000 IU/day vitamin A 6 months 1 Cap/Day 1 cap placebo/day for 6 month

with Multiple Sclerosis/ placebowith Multiple Sclerosis/ vitamin A

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS

You may not qualify if:

  • Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
  • Patients who have allergy to vitamin A compounds, OR
  • Patients who have used vitamin supplements in last 3 months. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences, School of Public Health

Tehran, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2011

First Posted

August 2, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

IR(1)