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Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594240
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nancy Samir Elbarbary, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plasma Homocysteine HbA1c Level Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) Dietary Supplement: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
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 .
 Dietary Supplement: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma homocysteine [ Time Frame: 12 weeks ]
    Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake


Secondary Outcome Measures :
  1. Change in HbA1c level [ Time Frame: 12 weeks ]
    Change in HbA1c level after 12 weeks of oral vitamin B complex intake


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594240


Locations
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Egypt
Nancy Elbarbary
Cairo, Egypt, 11361
Sponsors and Collaborators
Ain Shams University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nancy Samir Elbarbary, Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT03594240    
Other Study ID Numbers: Ain Shams Pediatrics 2082016
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Mainly clinical characteristics

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Nephropathies
Diabetes Mellitus
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Diabetes Complications
Folic Acid
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hematinics