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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
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, micronutrients, nephropathy, neuropathy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All Sexes

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

    First Posted
    July 30, 2010
    Last Updated
    July 30, 2010
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    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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