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

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: vitamin and mineral supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01173315

MFarvid

Details and patient eligibility

About

The combination of vitamin and mineral supplementation may improve:

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

75 participants in 3 patient groups, including a placebo group

Group MV

Experimental group

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

Treatment:

Dietary Supplement: vitamin and mineral supplementation

Group MVB

Experimental group

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)

Treatment:

Dietary Supplement: vitamin and mineral supplementation

Group P

Placebo Comparator group

Description:

Group P: starch (placebo

Treatment:

Dietary Supplement: vitamin and mineral supplementation