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

Obesity Clinical Trial

Official title:

Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691365
• Other study ID #: FMHS
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: September 19, 2012
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: United Arab Emirates University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: Ain Medical District Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
United Arab Emirates University	Tawam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infections		12 months	No
Primary	Inflammation		3 months	No
Primary	Oxidative damage		3 months	No
Secondary	Antioxidant status		3 months	No