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

This study has been completed.
Sponsor:
Collaborator:
Tawam Hospital
Information provided by (Responsible Party):
Salah Gariballa, United Arab Emirates University
ClinicalTrials.gov Identifier:
NCT01691365
First received: September 11, 2012
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Obesity
 Dietary Supplement: vitamins
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Arab Emirates University:

Primary Outcome Measures:
  • Inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Oxidative damage [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antioxidant status [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
MICROCRYSTALLINE CELLULOSE
 Drug: Placebo
Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691365

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

No publications provided

Responsible Party: Salah Gariballa, Professor, United Arab Emirates University
ClinicalTrials.gov Identifier: NCT01691365     History of Changes
Other Study ID Numbers: FMHS
Study First Received: September 11, 2012
Last Updated: September 19, 2012
Health Authority: United Arab Emirates: Ain Medical District Human Research Ethics Committee

Keywords provided by United Arab Emirates University:
Antioxidant
vitamins
Diet

Additional relevant MeSH terms:
Inflammation
Obesity
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Antioxidants
 Vitamin B Complex
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013