NCT01417273

Brief Summary

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.

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
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2010

Longer than P75 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

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

3 years

First QC Date

November 17, 2010

Last Update Submit

August 12, 2011

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple sclerosisimmune systemvitamin A(MSFC)Multiple Sclerosis Functional Composite(EDSS)Expanded Disability Status Scale(MRI)Magnetic resonance imaging

Outcome Measures

Primary Outcomes (5)

  • Expanded Disability Status Scale (EDSS)

    Expanded Disability Status Scale (EDSS) as a measure of activity and progression of MS disease

    Change from baseline at 12 months

  • Multiple Sclerosis Functional Composite (MSFC)

    Multiple Sclerosis Functional Composite (MSFC) as a measure of activity and progression of MS disease

    Change from baseline at 12 months

  • fatigue scores

    fatigue scores on Multiple Sclerosis Fatigue Impact Scale

    Change from baseline at 12 months

  • depression score

    depression score on Beck Depression Inventory 2

    Change from baseline at 12 months

  • Number of active lesion in magnetic resonance imaging (MRI) number of active lesion in brain MRI

    Number of active lesion in magnetic resonance imaging (MRI) as a measure of activity and progression of MS disease

    Change from baseline at 12 months

Secondary Outcomes (1)

  • number of disease relapses

    Change from baseline at 12 months

Study Arms (2)

vitamin A, multiple sclerosis,

ACTIVE COMPARATOR

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A for 6 months and 10000 IU/day for next 6 months

Dietary Supplement: vitamin ADrug: Drug: placebo

placebo/Multiple Sclerosis

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

1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months

placebo/Multiple Sclerosisvitamin A, multiple sclerosis,
Drug: placeboDRUG

1 cap placebo/day for 12 month

vitamin A, multiple sclerosis,

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 0-5 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,

Tehran, School of Public Health, Iran

Location

Related Publications (2)

  • Bitarafan S, Saboor-Yaraghi A, Sahraian MA, Soltani D, Nafissi S, Togha M, Beladi Moghadam N, Roostaei T, Mohammadzadeh Honarvar N, Harirchian MH. Effect of Vitamin A Supplementation on fatigue and depression in Multiple Sclerosis patients: A Double-Blind Placebo-Controlled Clinical Trial. Iran J Allergy Asthma Immunol. 2016 Feb;15(1):13-9.

    PMID: 26996107DERIVED

  • Bitarafan S, Saboor-Yaraghi A, Sahraian MA, Nafissi S, Togha M, Beladi Moghadam N, Roostaei T, Siassi F, Eshraghian MR, Ghanaati H, Jafarirad S, Rafiei B, Harirchian MH. Impact of Vitamin A Supplementation on Disease Progression in Patients with Multiple Sclerosis. Arch Iran Med. 2015 Jul;18(7):435-40.

    PMID: 26161708DERIVED

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 Officials

  • Ali Akbar saboor Yaraghi, PhD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Sama Bitarafan, MD, PhD student

    Tehran University of Medical Siences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2010

First Posted

August 16, 2011

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

IR(1)