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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: vitamin and mineral supplementation

• Registration Number: NCT01173315
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Study Timeline

• Status Verified: 2006-04
• Study Start: 2007-06
• Primary Completion: 2008-08
• Study Completion: 2009-09
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Last Update Submitted: 2010-07-30
• Study First Posted: 2010-08-02
• Last Update Posted: 2010-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group MV	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	vitamin and mineral supplementation	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	vitamin and mineral supplementation	Group P: starch (placebo

Primary Outcome Measures

Name	Time	Method
Evidence of clinically neuropathy confirmed by nerve conduction velocities	4 months	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

Name	Time	Method
nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit	4 months	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.