NCT01225289

Brief Summary

The aim of this study is to study the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and Th1/Th2 balance in patients with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 14, 2014

Completed
Last Updated

March 14, 2014

Status Verified

February 1, 2014

Enrollment Period

4.2 years

First QC Date

September 6, 2010

Results QC Date

October 29, 2013

Last Update Submit

February 12, 2014

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple SclerosisVitamin ACD4-Positive T-LymphocytesTh1 CellsTh2 Cells

Outcome Measures

Primary Outcomes (1)

  • Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation

    first day and after 6 month

Secondary Outcomes (3)

  • Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation

    first day and after 6 month

  • Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation

    first day and after 6 month

  • Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)

    first day and after 6 month

Study Arms (2)

with Multiple Sclerosis/ vitamin A

ACTIVE COMPARATOR

Patients with MS 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 per day

Drug: Placebo

Interventions

Vitamin ADIETARY_SUPPLEMENT

25000 IU/day (one capsule per day) Vitamin A for 6 months

Also known as: Retinyl palmitate
with Multiple Sclerosis/ vitamin A
PlaceboDRUG

1 capsule per day for six months

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 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 (2)

Tehran University of Medical Sciences, School of Public Health Tehran, Tehran, Iran, Islamic Republic o

Tehran, Tehran Province, Iran

Location

Tehran University of Medical Sciences, School of Public Health

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • Mohammadzadeh Honarvar N, Harirchian MH, Koohdani F, Siassi F, Abdolahi M, Bitarafan S, Salehi E, Sahraian MA, Eshraghian MR, Saboor-Yarghi AA. The effect of vitamin A supplementation on retinoic acid-related orphan receptor gammat (RORgammat) and interleukin-17 (IL-17) gene expression in Avonex-treated multiple sclerotic patients. J Mol Neurosci. 2013 Nov;51(3):749-53. doi: 10.1007/s12031-013-0058-9. Epub 2013 Jul 19.

    PMID: 23868508DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Vitamin Aretinol palmitate

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

Results Point of Contact

Title
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patien
Organization
Tehran University of Medical Sciences
sjafarirad@gmail.com
+98 912 2182815

Study Officials

  • Ali Akbar Saboor Yaraghi, PhD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Sima Jafarirad, PhD student

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 6, 2010

First Posted

October 21, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

March 14, 2014

Results First Posted

March 14, 2014

Record last verified: 2014-02

Locations

IR(2)