The Impact of Vitamins and Minerals Supplementation on Neuropathy and Nephropathy Complications
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
The combination of vitamin and mineral supplementation may improve:
- glycemic control
- lipid profile
- oxidative stress
- blood pressure
- nephropathy indices
- neuropathy indices
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Jun 2007
Typical duration for phase_2 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedAugust 2, 2010
April 1, 2006
1.2 years
July 30, 2010
July 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 months
Secondary Outcomes (1)
nephropathy indices were determined by 3 times urine microalbumin concentration using Enzyme Immuno Assay commercial kit
4 months
Study Arms (3)
Group MV
EXPERIMENTALGroup 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
EXPERIMENTALGroup 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
PLACEBO COMPARATORGroup P: starch (placebo
Interventions
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).
Eligibility Criteria
You may qualify if:
- Type 2 diabetes for 3 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21496936DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryam Sadat Farvid, Ph.D.
Shahid Beheshti University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 2, 2010
Study Start
June 1, 2007
Primary Completion
August 1, 2008
Study Completion
September 1, 2009
Last Updated
August 2, 2010
Record last verified: 2006-04