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| ID | Type | Description | Link |
|---|---|---|---|
| 0374/12 | Other Identifier | Federal University of ParaĆba Research Ethics Committee of the Center for Health Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol) |
|
| placebo group | Placebo Comparator | Placebo capsules with starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | High dose of 200,000 IU of cholecalciferol orally in a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of elderly women with sufficient vitamin D levels | four weeks after the intervention |
| Measure | Description | 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isa Gabriela M Cavalcante, DDS | Contact | +55 (83) 9112 0584 | isa.gabriela@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Isa Gabriela M Cavalcante, DDS | Federal University of ParaĆba | Principal Investigator |
| Maria da Conceição R GonƧalves, PDH | Federal University of ParaĆba | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program for Attention to Elderly, belonging to the Municipality of JoĆ£o Pessoa | Recruiting | JoĆ£o Pessoa | ParaĆba | Brazil |
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| Placebo | Dietary Supplement | Capsules of starch, no therapeutic action |
|
| 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 |
| Alexandre S Silva, PHD |
| Federal University of ParaĆba |
| Study Director |
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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