Phase 4
Completed N=36
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Source: ClinicalTrials.gov NCT01225289 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.