Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

NCT ID: NCT03594240

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-04-02

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.

Conditions

Plasma Homocysteine; HbA1c Level

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intervention group

Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.

Group Type: ACTIVE_COMPARATOR

Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)

Intervention Type: DRUG

Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily

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 .

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)

Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Samir Elbarbary

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nancy Elbarbary

Cairo, , Egypt

Countries

Egypt

References

Elbarbary NS, Ismail EAR, Zaki MA, Darwish YW, Ibrahim MZ, El-Hamamsy M. Vitamin B complex supplementation as a homocysteine-lowering therapy for early stage diabetic nephropathy in pediatric patients with type 1 diabetes: A randomized controlled trial. Clin Nutr. 2020 Jan;39(1):49-56. doi: 10.1016/j.clnu.2019.01.006. Epub 2019 Jan 17.

Reference Type: DERIVED

PMID: 30704890 (View on PubMed)

Other Identifiers

Ain Shams Pediatrics 2082016

Identifier Type: -

Identifier Source: org_study_id