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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02222649
Enrollment
40
Registered
2014-08-21
Start date
2014-07-31
Completion date
2015-09-30
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Aging

Keywords

Elderly, vitamin D insufficiency, High dose vitamin D3 supplementation, Polymorphism of the VDR gene

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

High dose of 200,000 IU of cholecalciferol orally in a single dose

DIETARY_SUPPLEMENTPlacebo

Capsules of starch, no therapeutic action

Sponsors

Federal University of Paraíba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
number of elderly women with sufficient vitamin D levelsfour weeks after the intervention

Secondary

MeasureTime frame
number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Proteinfour weeks after the intervention
number of elderly who have reduced serum levels of Alpha 1 Acid Glycoproteinfour 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 capacityfour weeks after the intervention

Other

MeasureTime frame
Number of Participants with Polymorphism of the VDR geneParticipants will be followed for the duration of recruitment , an expected average of 1 week

Countries

Brazil

Contacts

Primary ContactIsa Gabriela M Cavalcante, DDS
isa.gabriela@hotmail.com+55 (83) 9112 0584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026