- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594240
Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes
July 19, 2018 updated by: Nancy Samir Elbarbary, Ain Shams University
The Role of Vitamin B Complex as an Adjuvant Therapy for Diabetic Nephropathy in Pediatric Patients With Type 1 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 11361
- Nancy Elbarbary
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
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Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily
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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 .
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma homocysteine
Time Frame: 12 weeks
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Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c level
Time Frame: 12 weeks
|
Change in HbA1c level after 12 weeks of oral vitamin B complex intake
|
12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
April 2, 2018
Study Registration Dates
First Submitted
June 30, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Actual)
July 20, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ain Shams Pediatrics 2082016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Mainly clinical characteristics
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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