The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vitamin and mineral supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, micronutrients, nephropathy, neuropathy
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes for 3 years
Exclusion Criteria:
- Resting blood pressure >160/100 mmHg
- Taking vitamin and/or mineral supplement, thyroid hormones, estrogens, progesterone, diuretics or antihypertensive agents
- Having history of myocardial infarction and hepatic disease
- Pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group MV
Group MVB
Group P
Arm Description
Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg
Group MVB: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg)plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg)
Group P: starch (placebo
Outcomes
Primary Outcome Measures
Evidence of clinically neuropathy confirmed by nerve conduction velocities
nerve conduction velocities in the bilateral sural sensory nerves, and peroneal, tibial, median, and ulnar motor nerves with F waves in hands and legs extremity
Secondary Outcome Measures
nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit
Urine microalbumin concentration was measured by Enzyme Immuno Assay using commercial kit (ORG 5MA Micro Albumin, Orgentec Diagnostika GmbH, and Mainz, Germany). Urine total protein was determined by lowry method (19). Urine samples creatinine (Cr) were measured by chemical colorimetric kit according Jaffe reaction (Pars Azmoun, Tehran, Iran) and all urine results were expressed in relation to gram creatinine excretion.
Full Information
NCT ID
NCT01173315
First Posted
July 30, 2010
Last Updated
July 30, 2010
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01173315
Brief Title
The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications
Official Title
The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications in Type 2 Diabetic Patients: a Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
The combination of vitamin and mineral supplementation may improve:
glycemic control
lipid profile
oxidative stress
blood pressure
nephropathy indices
neuropathy indices
Detailed Description
A total of 75 diabetic patients (39 men and 36 women), aged 36 to 69 years, having diabetes for at least 3 years, was recruited for this study. Type 2 diabetes was defined as fasting plasma glucose 126 mg/dl (two times repeated) or taking oral glucose-lowering agents.Diabetic patients were stratified by sex and randomly assigned to one of the three treatment groups using block randomization procedure. Depending upon the treatment groups, each subject received two capsules per day, 1 with breakfast and 1 with dinner, for a period of 4 months. Each capsule contained one of the following preparations and hence determined the corresponding groups: Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg); Group MVB: both of the above mineral and vitamin supplements plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg); Group P: starch (placebo). All of the study medications, including the placebo, were supplied by Pharmaceutical Sciences Research Center (Tehran University of Medical Sciences, Iran) and were indistinguishable from each other. They were stored at 20-25 0C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, micronutrients, nephropathy, neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group MV
Arm Type
Experimental
Arm Description
Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg
Arm Title
Group MVB
Arm Type
Experimental
Arm Description
Group MVB: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg)plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg)
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
Group P: starch (placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin and mineral supplementation
Intervention Description
Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg); Group MVB: both of the above mineral and vitamin supplements plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg); Group P: starch (placebo).
Primary Outcome Measure Information:
Title
Evidence of clinically neuropathy confirmed by nerve conduction velocities
Description
nerve conduction velocities in the bilateral sural sensory nerves, and peroneal, tibial, median, and ulnar motor nerves with F waves in hands and legs extremity
Time Frame
4 months
Secondary Outcome Measure Information:
Title
nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit
Description
Urine microalbumin concentration was measured by Enzyme Immuno Assay using commercial kit (ORG 5MA Micro Albumin, Orgentec Diagnostika GmbH, and Mainz, Germany). Urine total protein was determined by lowry method (19). Urine samples creatinine (Cr) were measured by chemical colorimetric kit according Jaffe reaction (Pars Azmoun, Tehran, Iran) and all urine results were expressed in relation to gram creatinine excretion.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes for 3 years
Exclusion Criteria:
Resting blood pressure >160/100 mmHg
Taking vitamin and/or mineral supplement, thyroid hormones, estrogens, progesterone, diuretics or antihypertensive agents
Having history of myocardial infarction and hepatic disease
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Sadat Farvid, Ph.D.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21496936
Citation
Farvid MS, Homayouni F, Amiri Z, Adelmanesh F. Improving neuropathy scores in type 2 diabetic patients using micronutrients supplementation. Diabetes Res Clin Pract. 2011 Jul;93(1):86-94. doi: 10.1016/j.diabres.2011.03.016. Epub 2011 Apr 14.
Results Reference
derived
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The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications
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