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

Disorder of Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02222649
• Other study ID #: IGabriela
• Secondary ID: 0374/12
• Status: Recruiting
• Phase: Phase 2
• First received: August 15, 2014
• Last updated: March 4, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Federal University of Paraíba
• Contact: Isa Gabriela M Cavalcante, DDS
• Phone: +55 (83) 9112 0584
• Email: isa.gabriela[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Aging

Intervention

Dietary Supplement:
• Vitamin D3
High dose of 200,000 IU of cholecalciferol orally in a single dose
• Placebo
Capsules of starch, no therapeutic action

Locations

Country	Name	City	State
Brazil	Program for Attention to Elderly, belonging to the Municipality of João Pessoa	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Polymorphism of the VDR gene		Participants will be followed for the duration of recruitment , an expected average of 1 week	No
Primary	number of elderly women with sufficient vitamin D levels		four weeks after the intervention	No
Secondary	number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein		four weeks after the intervention	No
Secondary	number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein		four weeks after the intervention	No
Secondary	number of elderly who have reduced plasma levels of malondialdehyde (MDA)		four weeks after the intervention	No
Secondary	number of elderly that increased plasma antioxidant full capacity		four weeks after the intervention	No