Plain language summary
Multiple sclerosis (MS) is a relatively common chronic neurological disorder in which damage to the protective covering of neurons occurs in different areas of the central nervous system. Relapsing remitting multiple sclerosis (RRMS) is the relapsing episodes of MS and periods of stability in between relapses. The aim of this study was to determine the effect of vitamin B12 and folic acid supplementation on serum homocysteine (amino acid), anaemia status and quality of life of RRMS patients The study is a double-blind clinical trial which recruited 50 participants. The participants were randomly assigned to one of the 2 groups of RRMS: the vitamin group or the placebo group. Results indicate that increasing the consumption of folic acid and vitamin B12 improved physical and mental dimensions of quality of life in the vitamin group. However, in the placebo group, improvements were only limited to the psychological dimension of quality of life and no significant change in the physical dimension was observed. Authors conclude that homocysteine levels, anaemia status, and eventually quality of life of patients with MS can be significantly improved by administration of 1mg of vitamin B12 monthly and adding rich-food sources of folic acid on their diet.
Abstract
Plasma homocysteine level and megaloblastic anemia status are two factors that can affect the quality of life of patients with multiple sclerosis (MS). We conducted this study to determine the effect of vitamin B12 and folic acid supplementation on serum homocysteine, megaloblastic anemia status and quality of life of patients with MS. A total of 50 patients with relapsing remitting multiple sclerosis (RRMS) included in this study which divided into 2 groups. The vitamin group received 5 mg folic acid tablet daily and 3 doses of vitamin B12 (1,000 mcg) injection and the other group received placebo and normal saline injection (same doses). The quality of life was measured by using Multiple Sclerosis Quality of Life-54 questionnaire (MSQOL-54). Fully automated fluorescence polarization immunoassay was used to measure serum homocysteine, vitamin B12 and folate. Complete blood count blood test was conducted to determine the anemia status. The mean homocysteine level reduced by 2.49 ± 0.39 µmol/L (p = 0.001), hemoglobin increased from 11.24 ± 1.54 to 13.12 ± 1.05 g/dL (p = 0.001), and mean corpuscular volume decreased from 95.50 ± 6.65 to 89.64 ± 4.24 in the vitamin group (p = 0.001). There was a significant improvement in the mental field of life quality in the placebo group (37.46 ± 19.01 to 50.98 ± 21.64; p = 0.001), whereas both physical and mental fields of quality of life were improved significantly in the vitamin group (40.38 ± 15.07 to 59.21 ± 12.32 and 29.58 ± 15.99 to 51.68 ± 18.22, respectively; p = 0.001). Serum homocysteine level decrease and anemia status improvement with vitamin B12 and folic acid supplementation reveal the potential role of these two vitamins in improving the life quality of MS patients. TRIAL REGISTRATION Iranian Registry of Clinical Trials Identifier: IRCT2015100313678N7.
Methodological quality
Jadad score
:
3
Allocation concealment
:
Yes
