Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

NCT03594240 | Completed Phase 3 DMC

• 1 other identifier: Ain Shams Pediatrics 2082016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Homocysteine; HbA1c Level

Outcome Measures

Primary Outcomes (1)

• Change in plasma homocysteine

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

  12 weeks

Secondary Outcomes (1)

• Change in HbA1c level

  12 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

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

Control group

PLACEBO COMPARATOR

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 .

Dietary Supplement: Placebo

Interventions

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

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

intervention group

Placebo 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.

Control group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Nancy Elbarbary

Cairo, 11361, Egypt

Location

Related Publications (1)

• 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.

  PMID: 30704890 DERIVED

MeSH Terms

Interventions

Vitamin B Complex

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally and control group who did not receive B complex

Study Record Dates

• First Submitted: June 30, 2018
• First Posted: July 20, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 2, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

EG (1)