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Zinc Supplementation in Type 2 Diabetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309620
First Posted: March 7, 2011
Last Update Posted: March 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National University, Singapore
Information provided by:
National University Hospital, Singapore
  Purpose
Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in type 2 diabetics

Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent Dietary Supplement: Zinc gluconate Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Zinc Supplementation Reduce the Extent of Oxidative Stress Damage in Diabetics? A Randomised Placebo-controlled Study.

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Markers of oxidative damage [ Time Frame: Three months ]
    Isoprostanes, HETEs, cholesterol oxidation products, neuroprostanes, allantoin


Secondary Outcome Measures:
  • Vascular indices [ Time Frame: Three months ]
    Augmentation index and aortic pressure


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo, Twice Daily
Experimental: Zinc supplement Dietary Supplement: Zinc gluconate
Zinc gluconate (GNC, USA), 100 mg twice daily
Other Names:
  • Zinc gluconate (GNC, USA)
  • Zinc
  • Zinc supplementation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Subjects aged 21 years and above Subjects with type 2 diabetes mellitus

Exclusion criteria:

Those who consumed over-the counter or prescription drugs, vitamin/mineral supplements or traditional Chinese remedies Those who suffered acute infection less than 30-days prior to the start of the study Those who had been diagnosed with active neuropsychiatric disease or hematological diseases Those who had hemoglobin less than 10g/dL Those who had previous use of narcotic drugs or regular alcohol intake in excess of 14 units per week.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309620


Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Raymond CS Seet, MBBS National University Hospital, Singapore
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seet Chee Seong, Raymond, National University of Singapore
ClinicalTrials.gov Identifier: NCT01309620     History of Changes
Other Study ID Numbers: DSRB A/08/045
First Submitted: March 2, 2011
First Posted: March 7, 2011
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by National University Hospital, Singapore:
zinc, oxidative stress, vascular indices, type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs