Back to resultsVitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes
Primary Purpose
Plasma Homocysteine, HbA1c Level
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Plasma Homocysteine
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.
Sites / Locations
- Nancy Elbarbary
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
intervention group
Control group
Arm Description
Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.
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 .
Outcomes
Primary Outcome Measures
Change in plasma homocysteine
Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake
Secondary Outcome Measures
Change in HbA1c level
Change in HbA1c level after 12 weeks of oral vitamin B complex intake
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03594240
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Homocysteine, HbA1c Level
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
Intervention group included pediatric patients with diabetic nephropathy receiving oral vitamin B complex tablets( Neurorubine TM -Forte Lactab TM ) once daily.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)
Intervention Description
Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in plasma homocysteine
Description
Change in plasma homocysteine level after 12 weeks of oral vitamin B complex intake
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c level
Description
Change in HbA1c level after 12 weeks of oral vitamin B complex intake
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nancy Elbarbary
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Mainly clinical characteristics
Citations:
PubMed Identifier
30704890
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.
Results Reference
derived
Learn more about this trial
Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes
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