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Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients

NCT ID: NCT01691365

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

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Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit

Detailed Description

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Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins \[800 IU (727mg) of a-tocopherol and 500mg of vitamin C\] \[n=48\], or no supplements \[n= 48\] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis.

Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.

Conditions

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Diabetes Obesity

Keywords

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Antioxidant vitamins Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vitamins pills

antioxidant and B vitamins vitamins vitamin

\--------------------------------------------------------------------------------

Group Type ACTIVE_COMPARATOR

vitamins

Intervention Type DIETARY_SUPPLEMENT

a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days

pills

MICROCRYSTALLINE CELLULOSE

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)

Interventions

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vitamins

a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)

Intervention Type DRUG

Other Intervention Names

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Antioxidants B vitamins

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes mellitus

Exclusion Criteria

* severe chronic clinical or psychiatric disease,
* participating in other intervention trials,
* on dietary supplements and
* those unable to give an informed written consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tawam Hospital

OTHER

Sponsor Role collaborator

United Arab Emirates University

OTHER

Sponsor Role lead

Responsible Party

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Salah Gariballa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salah Gariballa, MD

Role: PRINCIPAL_INVESTIGATOR

United Arab Emirates University

References

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Gariballa S, Alkaabi J, Yasin J, Al Essa A. Total adiponectin in overweight and obese subjects and its response to visceral fat loss. BMC Endocr Disord. 2019 Jun 3;19(1):55. doi: 10.1186/s12902-019-0386-z.

Reference Type DERIVED
PMID: 31159801 (View on PubMed)

Other Identifiers

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FMHS

Identifier Type: -

Identifier Source: org_study_id