Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

• Status: Completed
• Trial end date: 2018-04-02
• Target enrollment: 0
• Participant gender: All

Summary

Homocysteine levels have been found elevated in T1DM patients with Diabetic nephropathy (DN) due to several causes, including dietary deficiencies. Hyperhomocysteinemia induces renal injury and is associated with increasing urinary albumin excretion(UAE). Therefore, the investigators performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for nephropathy in pediatric patients with T1DM and assessed its relation to homocysteine levels, glycemic control, microalbuminuria and cystatin C as a marker of nephropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Folic Acid; Vitamin B Complex; Vitamins

Criteria

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.