Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Vitamin C, Vitamin D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects in Mexico
Type 2 Diabetes Mellitus According to the World Health Organization (WHO), there are more
than 346 million individuals with diabetes, of which 90% are type 2. Global estimations for
the year 2030 predict an epidemic increase that will reach 366 million. According to the
National Nutrition and Health Survey of 2006 (ENSANUT2005), there are 6.4 million type 2
diabetic subjects in Mexico.
According to the calculation of the sample size, the investigators will include 120 adults
with type 2 diabetes mellitus selected from the outpatient preventive medicine offices of
health centres in the State of Mexico who will divided in two groups: supplement and placebo
(60 per group). After having been invited to participate and obtaining the informed consent,
study subjects will be evaluated for dietary information, as well as biochemical biomarkers
of metabolic control, anthropometric, immune and inflammatory markers, gut microbiota and
oxidative stress, before beginning the trial, and after 12 and 24 weeks of supplementation.
They will have a monthly follow-up visit for evaluation of adherence and adverse effects, as
well as delivery of the supplement.
Subjects will be randomly allocated to a supplementation with 1000 mg vitamin C, 400 IU vitamin D and 10 mg of zinc or placebo group, during 24 weeks. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding. ;
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