Trial Outcomes & Findings for Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients (NCT NCT01225289)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

first day and after 6 month

Results posted on

2014-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	18	18
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	With Multiple Sclerosis/ Vitamin A n=18 Participants Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 Participants Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.22 years STANDARD_DEVIATION 7.26 • n=5 Participants	31.05 years STANDARD_DEVIATION 5.94 • n=7 Participants	32.17 years STANDARD_DEVIATION 6.64 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: first day and after 6 month

Outcome measures

Outcome measures
Measure	With Multiple Sclerosis/ Vitamin A n=18 Participants Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 Participants Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation	1.2 mg/L Standard Error 0.5	-0.6 mg/L Standard Error 0.4

SECONDARY outcome

Timeframe: first day and after 6 month

Outcome measures

Outcome measures
Measure	With Multiple Sclerosis/ Vitamin A n=18 Participants Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 Participants Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation	2.5 pg/ml Standard Error 1.2	1.5 pg/ml Standard Error 1

SECONDARY outcome

Timeframe: first day and after 6 month

Outcome measures

Outcome measures
Measure	With Multiple Sclerosis/ Vitamin A n=18 Participants Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 Participants Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation	0.2 ratio Standard Error 0.2	-0.4 ratio Standard Error 0.5

SECONDARY outcome

Timeframe: first day and after 6 month

difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation

Outcome measures

Outcome measures
Measure	With Multiple Sclerosis/ Vitamin A n=18 Participants Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 Participants Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)	-0.06 absorbance units Standard Error 0.08	-0.13 absorbance units Standard Error 0.09

Adverse Events

With Multiple Sclerosis/ Vitamin A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

With Multiple Sclerosis/ Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	With Multiple Sclerosis/ Vitamin A n=18 participants at risk Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A	With Multiple Sclerosis/ Placebo n=17 participants at risk Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
Nervous system disorders MS relapsing	0.00% 0/18	5.9% 1/17 • Number of events 1

Additional Information

The Study of the Effects of Vitamin A Supplementation on Immune System and Th1/Th2 Balance in Patien

Tehran University of Medical Sciences

Phone: +98 912 2182815

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place