Clinical trial NCT01173315: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
micronutrients
nephropathy
neuropathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evidence of clinically neuropathy confirmed by nerve conduction velocities
timeFrame: 4 months
Secondary outcomes:
measure: nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Maryam Sadat Farvid, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.