Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

This trial included 80 vitamin B12-deficient T1DM patients with nephropathy, despite oral angiotensin-converting enzyme inhibitors . Enrolled patients aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally . 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, cystatin C and UAE.

Inclusion criteria

• Patients with type 1 diabetes.
• Patients aged 12-18 years with at least 5 years disease duration.
• Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion [UAE] 30-299 mg/g creatinine in two of three samples over a 3- to 6- months period despite angiotensin converting enzyme inhibitors)
• Hemoglobin A1c (HbA1c) ≤8.5%
• Patients on regular visit to clinic.
• Patients on regular insulin therapy.

Exclusion criteria

Patients were excluded if they have any of the following:

• Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
• Patients with any evidence of renal impairment due to cause other than diabetes.
• Patients with hypertension.
• Hepatitis virus infection (B or C) or any evidence of infection.
• Taking any vitamins or food supplements one month before study.
• Participation in a previous investigational drug study within 3 months preceding screening.