Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01225289
First received: September 6, 2010
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Dietary Supplement: Vitamin A
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
With Multiple Sclerosis/ Vitamin A Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
With Multiple Sclerosis/ Placebo Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day

Participant Flow:   Overall Study
    With Multiple Sclerosis/ Vitamin A     With Multiple Sclerosis/ Placebo  
STARTED     18     18  
COMPLETED     18     17  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
With Multiple Sclerosis/ Vitamin A Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
With Multiple Sclerosis/ Placebo Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Total Total of all reporting groups

Baseline Measures
    With Multiple Sclerosis/ Vitamin A     With Multiple Sclerosis/ Placebo     Total  
Number of Participants  
[units: participants]
  18     17     35  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     17     35  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.22  ± 7.26     31.05  ± 5.94     32.17  ± 6.64  
Gender  
[units: participants]
     
Female     13     13     26  
Male     5     4     9  
Region of Enrollment  
[units: participants]
     
Iran, Islamic Republic of     18     17     35  



  Outcome Measures
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1.  Primary:   Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation   [ Time Frame: first day and after 6 month ]

2.  Secondary:   Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation   [ Time Frame: first day and after 6 month ]

3.  Secondary:   Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation   [ Time Frame: first day and after 6 month ]

4.  Secondary:   Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)   [ Time Frame: first day and after 6 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/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
phone: +98 912 2182815
e-mail: sjafarirad@gmail.com


No publications provided by Tehran University of Medical Sciences

Publications automatically indexed to this study:

Responsible Party: Ali Akbar Saboor Yaraghi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01225289     History of Changes
Other Study ID Numbers: 88-03-27-9576
Study First Received: September 6, 2010
Results First Received: October 29, 2013
Last Updated: February 12, 2014
Health Authority: Iran: Ministry of Health