Multiple Sclerosis treated by 50,000 IU Vitamin D bi-weekly plus Omega-3 – RCT
High-dose ω-3 Fatty Acid Plus Vitamin D3 Supplementation Affects Clinical Symptoms and Metabolic Status of Patients with Multiple Sclerosis: A Randomized Controlled Clinical Trial
The Journal of Nutrition, nxy116, https://doi.org/10.1093/jn/nxy116
Ebrahim Kouchaki Maryam Afarini Javad Abolhassani Naghmeh Mirhosseini Fereshteh Bahmani Seyed Ali Masoud Zatollah Asemi
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Background: Combined omega-3 fatty acid and vitamin D supplementation may improve multiple sclerosis (MS) by correcting metabolic abnormalities and attenuating oxidative stress and inflammation.
Objective: This study aimed to determine the effects of ω-3 fatty acid and vitamin D cosupplementation on the disability score and metabolic status of patients with MS.
Methods
This was a randomized, placebo-controlled clinical trial with Expanded Disability Status Scale (EDSS) score and inflammation as primary outcomes and oxidative stress biomarkers and metabolic profile as secondary outcomes. Patients, aged 18–55 y, were matched for disease EDSS scores, gender, medications, BMI, and age (n = 53) and randomly received a combined 2 × 1000 mg/d ω-3 fatty acid and 50,000 IU/biweekly cholecalciferol supplement or placebo for 12 wk. The placebos were matched in colour, shape, size, packaging, smell, and taste with supplements. Fasting blood samples were collected at baseline and end of intervention to measure different outcomes. Multiple linear regression models were used to assess treatment effects on outcomes adjusting for confounding variables.
Results
Patients taking ω-3 fatty acid plus vitamin D supplements showed a significant improvement in
EDSS (β −0.18; 95% CI: −0.33, −0.04; P = 0.01), compared with placebo.
Serum high-sensitivity C-reactive protein (β −1.70 mg/L; 95% CI: −2.49, −0.90 mg/L; P < 0.001),
plasma total antioxidant capacity (β +55.4 mmol/L; 95% CI: 9.2, 101.6 mmol/L; P = 0.02),
total glutathione (β +51.14 µmol/L; 95% CI: 14.42, 87.87 µmol/L; P = 0.007), and
malondialdehyde concentrations (β −0.86 µmol/L; 95% CI: −1.10, −0.63 µmol/L; P < 0.001)
were significantly improved in the supplemented group compared with the placebo group.
In addition, ω-3 fatty acid and vitamin D cosupplementation resulted in a significant reduction in
serum insulin,
insulin resistance, and
total/HDL-cholesterol,
and a significant increase in
insulin sensitivity and
serum HDL-cholesterol concentrations.
Conclusion
Overall, taking ω-3 fatty acid and vitamin D supplements for 12 wk by patients with MS had beneficial effects on EDSS and metabolic status.
This trial was registered at the Iranian website (www.irct.ir) for registration of clinical trials as IRCT2017090133941N20.