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

United Arab Emirates University

Status and phase: Completed; Phase 4

Conditions: Diabetes; Obesity

Treatments: Dietary Supplement: vitamins; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01691365

FMHS

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

vitamins pills

Active Comparator group

Description:

antioxidant and B vitamins vitamins vitamin --------------------------------------------------------------------------------

Treatment:

Dietary Supplement: vitamins

pills

Placebo Comparator group

Description:

MICROCRYSTALLINE CELLULOSE

Treatment:

Drug: Placebo