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| Name | Class |
|---|---|
| Tawam Hospital | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamins pills | Active Comparator | antioxidant and B vitamins vitamins vitamin -------------------------------------------------------------------------------- |
|
| pills | Placebo Comparator | MICROCRYSTALLINE CELLULOSE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamins | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | 3 months | |
| Oxidative damage | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant status | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infections | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salah Gariballa, MD | United Arab Emirates University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31159801 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| D000975 | Antioxidants |
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Placebo | Drug | Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide) |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D001685 | Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020011 | Protective Agents |
| D020313 | Specialty Uses of Chemicals |