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

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. Identifier: NCT01691365
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Tawam Hospital
Information provided by (Responsible Party):
Salah Gariballa, United Arab Emirates University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Obesity Dietary Supplement: vitamins Drug: Placebo Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
Study Start Date : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: vitamins pills

antioxidant and B vitamins vitamins vitamin

Dietary Supplement: 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
Other Names:
  • Antioxidants
  • B vitamins

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

Primary Outcome Measures :
  1. Inflammation [ Time Frame: 3 months ]
  2. Oxidative damage [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Antioxidant status [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Infections [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01691365

Sponsors and Collaborators
United Arab Emirates University
Tawam Hospital
Principal Investigator: Salah Gariballa, MD United Arab Emirates University

Responsible Party: Salah Gariballa, Professor, United Arab Emirates University Identifier: NCT01691365     History of Changes
Other Study ID Numbers: FMHS
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by Salah Gariballa, United Arab Emirates University:

Additional relevant MeSH terms:
Pathologic Processes
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents