The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01173315
First received: July 30, 2010
Last updated: NA
Last verified: April 2006
History: No changes posted

July 30, 2010
July 30, 2010
June 2007
August 2008   (final data collection date for primary outcome measure)
Evidence of clinically neuropathy confirmed by nerve conduction velocities [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications
The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications in Type 2 Diabetic Patients: a Randomised Clinical Trial

The combination of vitamin and mineral supplementation may improve:

  • glycemic control
  • lipid profile
  • oxidative stress
  • blood pressure
  • nephropathy indices
  • neuropathy indices

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Dietary Supplement: vitamin and mineral supplementation
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).
  • Experimental: Group MV
    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
    Intervention: Dietary Supplement: vitamin and mineral supplementation
  • Experimental: Group MVB
    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)
    Intervention: Dietary Supplement: vitamin and mineral supplementation
  • Placebo Comparator: Group P
    Group P: starch (placebo
    Intervention: Dietary Supplement: vitamin and mineral supplementation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
September 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01173315
MFarvid
Not Provided
Dr Majid Hajifaraji, National Nutrition and Food Technology Research Institute
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Maryam Sadat Farvid, Ph.D. Shahid Beheshti Medical University
Shahid Beheshti Medical University
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP