Clinical trial NCT03594240: Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes
Official title: The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasma Homocysteine
HbA1c Level
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in plasma homocysteine
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in HbA1c level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nancy Elbarbary
Study officials:
References:
citation: 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.