Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

July 19, 2018 updated by: Nancy Samir Elbarbary, Ain Shams University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11361
        • Nancy Elbarbary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention group
Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.
Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily
Placebo Comparator: Control group
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 .
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma homocysteine
Time Frame: 12 weeks
Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c level
Time Frame: 12 weeks
Change in HbA1c level after 12 weeks of oral vitamin B complex intake
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 2, 2018

Study Registration Dates

First Submitted

June 30, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Mainly clinical characteristics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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