NCT03594240

Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Plasma Homocysteine
• HbA1c Level

Interventions

Type	Name	Description
DRUG	Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)	Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily
DIETARY_SUPPLEMENT	Placebo	Patients in placebo group received placebo that were similar in appearance to Vitamin B complex tablets and the administered dose was as the same schedule as Vitamin B complex.

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-03-01
• Completion: 2018-04-02
• First posted: 2018-07-20
• Last updated: 2018-07-20

Locations

1 site across 1 country: Egypt