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NCT03734445

Effect of Vitamin C, D and Zinc Supplementation on the Immune and Inflammatory Process in Type 2 Diabetic Subjects

Status unknown NA Last updated 1 October 2019
What this trial tests

NA trial testing Vitamin Supplement in Diabetes Mellitus, Type 2 in 120 participants. Status unknown.

Timeline
9 January 2020
Primary endpoint
9 January 2020
26 March 2020

Quick facts

Lead sponsorUniversidad Autonoma del Estado de Mexico
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment120
Start date9 January 2020
Primary completion9 January 2020
Estimated completion26 March 2020

Drugs / interventions tested

Conditions studied

Sponsor

Universidad Autonoma del Estado de Mexico

Who can join

Adults 25 to 55, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Universidad Autonoma del Estado de Mexico trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03734445.

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