NCT01309620

Brief Summary

Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in type 2 diabetics

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Status
completed

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

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 2, 2011

Last Update Submit

March 3, 2011

Conditions

Keywords

zinc, oxidative stress, vascular indices, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Markers of oxidative damage

    Isoprostanes, HETEs, cholesterol oxidation products, neuroprostanes, allantoin

    Three months

Secondary Outcomes (1)

  • Vascular indices

    Three months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Zinc supplement

EXPERIMENTAL
Dietary Supplement: Zinc gluconate

Interventions

Zinc gluconateDIETARY_SUPPLEMENT

Zinc gluconate (GNC, USA), 100 mg twice daily

Also known as: Zinc gluconate (GNC, USA), Zinc, Zinc supplementation
Zinc supplement
PlaceboDIETARY_SUPPLEMENT

Placebo, Twice Daily

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seet RC, Lee CY, Lim EC, Quek AM, Huang H, Huang SH, Looi WF, Long LH, Halliwell B. Oral zinc supplementation does not improve oxidative stress or vascular function in patients with type 2 diabetes with normal zinc levels. Atherosclerosis. 2011 Nov;219(1):231-9. doi: 10.1016/j.atherosclerosis.2011.07.097. Epub 2011 Jul 26.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

gluconic acidZinc

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Raymond CS Seet, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 7, 2011

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

March 7, 2011

Record last verified: 2011-03