Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

HbA1c Level Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594240
• Other study ID #: Ain Shams Pediatrics 2082016
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: April 2, 2018

Study information

• Verified date: July 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• HbA1c Level
• Plasma Homocysteine

Intervention

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.

Locations

Country	Name	City	State
Egypt	Nancy Elbarbary	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma homocysteine	Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake	12 weeks
Secondary	Change in HbA1c level	Change in HbA1c level after 12 weeks of oral vitamin B complex intake	12 weeks