Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Plasma Homocysteine, HbA1c Level

Intervention / Treatment
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* Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br>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)<br>* Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily<br>|
| Placebo Comparator: Control group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma homocysteine | 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 | Change in HbA1c level after 12 weeks of oral vitamin B complex intake | 12 weeks |