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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT02222649 |
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Date of registration:
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15/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02222649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maria da Conceição R Gonçalves, PDH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Paraíba |
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Name:
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Isa Gabriela M Cavalcante, DDS |
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Address:
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Telephone:
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+55 (83) 9112 0584 |
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Email:
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isa.gabriela@hotmail.com |
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Affiliation:
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Name:
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Isa Gabriela M Cavalcante, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Paraíba |
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Name:
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Isa Gabriela M Cavalcante, DDS |
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Address:
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Telephone:
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+55 (83) 9112 0584 |
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Email:
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isa.gabriela@hotmail.com |
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Affiliation:
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Name:
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Alexandre S Silva, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Paraíba |
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Key inclusion & exclusion criteria
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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.
Age minimum:
60 Years
Age maximum:
90 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Disorder of Aging
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Vitamin D3
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Primary Outcome(s)
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number of elderly women with sufficient vitamin D levels
[Time Frame: four weeks after the intervention]
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Secondary Outcome(s)
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number of elderly who have reduced plasma levels of malondialdehyde (MDA)
[Time Frame: four weeks after the intervention]
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number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein
[Time Frame: four weeks after the intervention]
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number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein
[Time Frame: four weeks after the intervention]
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number of elderly that increased plasma antioxidant full capacity
[Time Frame: four weeks after the intervention]
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Secondary ID(s)
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0374/12
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IGabriela
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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