Background: Diabetic nephropathy (DN) is a major microvascular complica-tion of type 1 diabetes mellitus (T1DM). Homocysteine levels have been found elevated in T1DM patients with DN due to several causes, including dietary deficiencies of folic acid and B Vitamins. Hyperhomocysteinemia induces renal injury and is associated with increasing urinary albumin excretion in patients with diabetes. We therefore performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for diabetic nephropathy in children and adolescents and assessed its relation to homocysteine levels, glycemic control, microalbuminuria and cystatin C as a marker of nephropathy.
Methods: This trial included 80 vitamin B12-deficient type 1 diabetic patients with nephropathy, despite oral angiotensin-converting enzyme inhibitors (ACE-Is). Enrolled patients aged 12-18 years with at least 5 years disease duration and hemoglobin A1c (HbA1c) ≤8.5%. Patients were randomly assigned into two groups; intervention group who received oral supplementation with vitamin B complex once daily (Neurorubine TM Forte Lactab TM Mepha Pharma Egypt S.A.E manufactured by Medical Union Pharmaceuticals).The tablet is composed of Vitamin B1 200 mg, Vitamin B6 50 mg and Vitamin B12 1000 μg. The other group did not receive any supplementation and served as a control group. Both groups were followed-up for 12 weeks with assessment of plasma homocysteine, HbA1c, urinary albumin excretion (UAE) and cystatin C.
Results: The subjects in the trial groups were well matched in baseline clinical characteristics and laboratory parameters (P>0.05). Baseline homocysteine levels were elevated in both groups compared with reference control values. After 12 weeks, supplementation with vitamin B complex resulted in significant decrease of plasma homocysteine, fasting blood glucose, HbA1c, total cholesterol, triglycerides, UAE and cystatin C compared with baseline levels (P<0.001) in intervention group and compared with control group (P<0.001). No adverse reactions due to vitamin B complex were reported. Baseline vitamin B12 was positively correlated to UAE (r=−0.877, P=0.009) and cystatin C (r=−0.77, P=0.043) while negatively correlated with homocysteine levels among DN patients with vitamin B adjuvant therapy.
Conclusions: Oral supplementation with vitamin B complex for 12 weeks improved glycemic control and renal function through decreasing plasma homocysteine. Thus, it could be a safe and effective strategy for treatment of pediatric type 1 diabetic patients with nephropathy.
27 Sep 2018 - 29 Sep 2018