Vitamin D treatment of diabetes (50,000 IU every 2 weeks) augmented by probiotic – RCT
The effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial.
Prog Neuropsychopharmacol Biol Psychiatry. 2018 Jun 8;84(Pt A):50-55. doi: 10.1016/j.pnpbp.2018.02.007. Epub 2018 Feb 9.
Raygan F1, Ostadmohammadi V2, Bahmani F3, Asemi Z4.
BACKGROUND:
This study was carried out to evaluate the effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in diabetic people with coronary heart disease (CHD).
METHODS:
This randomized, double-blind, placebo-controlled trial was carried out among 60 diabetic people with CHD, aged 45-85 years old. Subjects were randomly allocated into two groups to receive either 50,000 IU vitamin D every 2 weeks plus 8 × 109 CFU/g probiotic of Lactocare Zisttakhmir Co (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were obtained at baseline and after the 12-week intervention to determine metabolic profiles.
RESULTS:
After the 12-week intervention, compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant improvements in
beck depression inventory total score (-2.8 ± 3.8 vs. -0.9 ± 2.1, P = 0.01),
beck anxiety inventory scores (-2.1 ± 2.3 vs. -0.8 ± 1.4, P = 0.009) and
general health questionnaire scores (-3.9 ± 4.1 vs. -1.1 ± 3.4, P = 0.005).
Compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant reductions in
serum insulin levels (-2.8 ± 3.8 vs. +0.2 ± 4.9 μIU/mL, P = 0.009),
homeostasis model of assessment-estimated insulin resistance (-1.0 ± 1.6 vs. -0.1 ± 1.5, P = 0.02),
and a significant increase in
serum 25-OH-vitamin D (+11.8 ± 5.9 vs. +0.1 ± 1.4 ng/mL, P < 0.001),
the quantitative insulin sensitivity check index (+0.03 ± 0.04 vs. -0.001 ± 0.01, P = 0.003) and
serum HDL-cholesterol levels (+2.3 ± 3.5 vs. -0.5 ± 3.8 mg/dL, P = 0.004).
In addition, changes in
serum high sensitivity C-reactive protein (hs-CRP) (-950.0 ± 1811.2 vs. +260.5 ± 2298.2 ng/mL, P = 0.02),
plasma nitric oxide (NO) (+1.7 ± 4.0 vs. -1.4 ± 6.7 μmol/L, P = 0.03) and
plasma total antioxidant capacity (TAC) (+12.6 ± 41.6 vs. -116.9 ± 324.2 mmol/L, P = 0.03)
in the supplemented group were significantly different from the changes in these indicators in the placebo group.
CONCLUSIONS:
Overall, vitamin D and probiotic co-supplementation after 12 weeks among diabetic people with CHD had beneficial effects on mental health parameters, serum hs-CRP, plasma NO, TAC, glycemic control and HDL-cholesterol levels.
CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir: IRCT2017073033941N4.