Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

Phase 3

Completed

• Conditions: Plasma Homocysteine; HbA1c Level
• Interventions: Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM); Dietary Supplement: Placebo

• Registration Number: NCT03594240
• Lead Sponsor: Ain Shams University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-04-02
• Study First Submitted: 2018-06-30
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-20
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)	Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.
Control group	Placebo	Placebo group or control patients 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 .

Primary Outcome Measures

Name	Time	Method
Change in plasma homocysteine	12 weeks	Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c level	12 weeks	Change in HbA1c level after 12 weeks of oral vitamin B complex intake

Trial Locations

Locations (1)

Nancy Elbarbary; 🇪🇬 Cairo, Egypt