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

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.

Study Overview

• Status: Unknown
• Conditions: Disorder of Aging
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Isa Gabriela M Cavalcante, DDS; Phone Number: +55 (83) 9112 0584; Email: isa.gabriela@hotmail.com

Study Locations

• Brazil
  • Paraíba
    • João Pessoa, Paraíba, Brazil
      • Recruiting
      • Program for Attention to Elderly, belonging to the Municipality of João Pessoa
      • Contact: Isa Gabriela M Cavalcante, DDS; Phone Number: +55 (83) 9112 0584; Email: isa.gabriela@hotmail.com
      • Contact: DDS
      • Principal Investigator: Isa Gabriela M Cavalcante, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D3; Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol)	Dietary supplement: Vitamin D3; High dose of 200,000 IU of cholecalciferol orally in a single dose; Other Names: cholecalciferol; High dose
Placebo Comparator: placebo group; Placebo capsules with starch	Dietary supplement: Placebo; Capsules of starch, no therapeutic action

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of elderly women with sufficient vitamin D levels	four weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Polymorphism of the VDR gene	Participants will be followed for the duration of recruitment , an expected average of 1 week

Collaborators and Investigators

• Sponsor: Federal University of Paraíba
• Investigators: Principal Investigator: Isa Gabriela M Cavalcante, DDS, Federal University of Paraíba; Study Director: Maria da Conceição R Gonçalves, PDH, Federal University of Paraíba; Study Director: Alexandre S Silva, PHD, Federal University of Paraíba

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: August 20, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Elderly; vitamin D insufficiency; High dose vitamin D3 supplementation; Polymorphism of the VDR gene
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: IGabriela; 0374/12 (Other Identifier: Federal University of Paraíba Research Ethics Committee of the Center for Health Sciences)