NCT02222649

Evaluation of the High Dose Vitamin D3 Supplementation Effect and Influence of Polymorphism VDR Gene on Oxidative Stress and Inflammatory Process in Elderly

EVALUATION OF THE HIGH DOSE VITAMIN D3 SUPPLEMENTATION EFFECT AND INFLUENCE OF POLYMORPHISM VDR GENE ON OXIDATIVE STRESS AND INFLAMMATORY PROCESS IN ELDERLY

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: Female
• Age: 60 Years – 90 Years
• Healthy volunteers: Accepted

Summary

A vitamin D3 high dose would act as an antioxidant and anti-inflammatory improving markers of oxidative stress and inflammation in the elderly. Seniors exhibiting polymorphism in the VDR gene would become non-responsive to supplementation.

Detailed description

The high prevalence of hypovitaminosis D in the elderly can be identified as a risk factor for developing cardiovascular disease and consequent increase in oxidative stress and chronic inflammation. Polymorphisms in the gene that encodes the vitamin D receptor (VDR) can influence the cellular responses supplementation of vitamin D. The study objective is to evaluate the influence of supplementation of 200,000 in a single high dose of vitamin D3 in the inflammatory status and oxidative stress elderly and the influence of polymorphism of the VDR gene in this response. One randomized, placebo-controlled clinical trial, designed with non-institutionalized elderly in northeastern Brazil will be held. All volunteers will sign the Instrument of Consent and will undergo clinical, nutritional, anthropometric and biochemical evaluation. The purpose is to produce new knowledge helping to unravel the beneficial effects of vitamin D3.

Conditions

• Disorder of Aging

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3	High dose of 200,000 IU of cholecalciferol orally in a single dose
DIETARY_SUPPLEMENT	Placebo	Capsules of starch, no therapeutic action

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-05-01
• Completion: 2015-09-01
• First posted: 2014-08-21
• Last updated: 2015-03-06

Locations

1 site across 1 country: Brazil