Impact of Vitamin A Supplementation on Immune System in Multiple Scler
The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patients With Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation | <0.01 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Retinol
Placebo
- Placebo
Results by group
Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation
first day and after 6 month
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| With Multiple Sclerosis/ Vitamin A | 1.2 mg/L | 0.5 (Standard Error) | 18 |
| With Multiple Sclerosis/ Placebo | -0.6 mg/L | 0.4 (Standard Error) | 17 |
With Multiple Sclerosis/ Vitamin A
With Multiple Sclerosis/ Placebo
p = <0.01
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| With Multiple Sclerosis/ Vitamin A | 18 | 0 (0.0%) | |
| With Multiple Sclerosis/ Placebo | 17 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation
first day and after 6 month
Other measures (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
Immune responseDifference 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
Who could take part
Relapsing MS · 20 to 45
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Oct 2009
Main results due
Dec 2013
Finished
Jan 2014
Results posted
Mar 2014