Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients
Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes
Started Sep 2008
Typical duration for phase_4 diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 24, 2012
CompletedSeptember 24, 2012
September 1, 2012
1.2 years
September 11, 2012
September 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Inflammation
3 months
Oxidative damage
3 months
Secondary Outcomes (1)
Antioxidant status
3 months
Other Outcomes (1)
Infections
12 months
Study Arms (2)
vitamins pills
ACTIVE COMPARATORantioxidant and B vitamins vitamins vitamin \--------------------------------------------------------------------------------
pills
PLACEBO COMPARATORMICROCRYSTALLINE CELLULOSE
Interventions
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
Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes mellitus
You may not qualify if:
- severe chronic clinical or psychiatric disease,
- participating in other intervention trials,
- on dietary supplements and
- those unable to give an informed written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United Arab Emirates Universitylead
- Tawam Hospitalcollaborator
Related Publications (1)
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.
PMID: 31159801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salah Gariballa, MD
United Arab Emirates University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 24, 2012
Study Start
September 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2011
Last Updated
September 24, 2012
Record last verified: 2012-09