Phase 4
N=36
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Relapsing Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01225289 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation — 1.2; -0.6 mg/L — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vitamin A (Dietary_supplement); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tehran University of Medical Sciences
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation |
1.2; -0.6 | <0.01 sig |
| SECONDARY Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation |
2.5; 1.5 | — |
| SECONDARY Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation |
0.2; -0.4 | — |
| SECONDARY Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric) |
-0.06; -0.13 | — |
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.
Eligibility Criteria
Inclusion Criteria
Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01225289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.