NCT01705457

Brief Summary

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor expression.

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
20

participants targeted

Target at below P25 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
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
4 months 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

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

October 9, 2012

Last Update Submit

October 11, 2012

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

multiple sclerosisVitamin Aretinoic acid receptorretinoic x receptor

Outcome Measures

Primary Outcomes (1)

  • Gene expression of RAR(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

Drug: Dietary Supplement: vitamin A

with multiple sclerosis,placebo

PLACEBO COMPARATOR

Patients with Multiple Sclerosis confirmed Relapsing Remitting Type

Drug: placebo

Interventions

Dietary Supplement: vitamin ADRUG

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

Also known as: Retinyl palmitate
with Multiple Sclerosis, vitamin A
placeboDRUG
with multiple sclerosis,placebo

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, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

retinol palmitate

Condition Hierarchy (Ancestors)

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

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
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

October 9, 2012

First Posted

October 12, 2012

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

August 1, 2013

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

IR(1)