Clinical trial NCT02222649: Evaluation of the High Dose Vitamin D3 Supplementation Effect and Influence of Polymorphism VDR Gene on Oxidative Stress and Inflammatory Process in Elderly
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Disorder of Aging
Keywords: Elderly
vitamin D insufficiency
High dose vitamin D3 supplementation
Polymorphism of the VDR gene
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of elderly women with sufficient vitamin D levels
timeFrame: four weeks after the intervention
Secondary outcomes:
measure: number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein
timeFrame: four weeks after the intervention
measure: number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein
timeFrame: four weeks after the intervention
measure: number of elderly who have reduced plasma levels of malondialdehyde (MDA)
timeFrame: four weeks after the intervention
measure: number of elderly that increased plasma antioxidant full capacity
timeFrame: four weeks after the intervention
Other outcomes:
measure: Number of Participants with Polymorphism of the VDR gene
timeFrame: Participants will be followed for the duration of recruitment , an expected average of 1 week
Locations:
city: João Pessoa
country: Brazil
facility: Program for Attention to Elderly, belonging to the Municipality of João Pessoa
state: Paraíba
Study officials:
affiliation: Federal University of Paraíba
name: Isa Gabriela M Cavalcante, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Paraíba
name: Maria da Conceição R Gonçalves, PDH
role: STUDY_DIRECTOR
affiliation: Federal University of Paraíba
name: Alexandre S Silva, PHD
role: STUDY_DIRECTOR
References: