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

Phase 2

• Conditions: Disorder of Aging
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT02222649
• Lead Sponsor: Federal University of Paraíba

Brief 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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2014-08
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-20
• Study First Posted: 2014-08-21
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06
• Primary Completion: 2015-05
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the exclusion criteria

Exclusion Criteria

• excluded from the study in the elderly using vitamin D supplements; anticonvulsant drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus, nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism, hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or smoker chronic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol)
placebo group	Placebo	Placebo capsules with starch

Primary Outcome Measures

Name	Time	Method
number of elderly women with sufficient vitamin D levels	four weeks after the intervention

Secondary Outcome Measures

Name	Time	Method
number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein	four weeks after the intervention
number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein	four weeks after the intervention
number of elderly who have reduced plasma levels of malondialdehyde (MDA)	four weeks after the intervention
number of elderly that increased plasma antioxidant full capacity	four weeks after the intervention

Trial Locations

Locations (1)

Program for Attention to Elderly, belonging to the Municipality of João Pessoa; 🇧🇷 João Pessoa, Paraíba, Brazil