ESPE Abstracts

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.