Disorder of AgingPhase 2NCT02222649
Evaluation of the High Dose Vitamin D3 Supplementation Effect and Influence of Polymorphism VDR Gene on Oxidative Stress and Inflammatory Process in Elderly
A Phase 2 study testing Vitamin D3 in people with Disorder of Aging, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disorder of Aging
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Program for Attention to Elderly, belonging to the Municipality of João Pessoa
João Pessoa, Paraíba
Isa Gabriela M Cavalcante, DDS, +55 (83) 9112 0584, isa.gabriela@hotmail.com
DDS
About this study
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
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.
Read the 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.
- Conditions
- Disorder of Aging
- Being tested
- Vitamin D3, Placebo
- Keywords
- Elderly, vitamin D insufficiency, High dose vitamin D3 supplementation, Polymorphism of the VDR gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol, High dose
High dose of 200,000 IU of cholecalciferol orally in a single dose
PlaceboDietary supplement
Capsules of starch, no therapeutic action
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol) Receives: Dietary Supplement: Vitamin D3 |
| placebo group | Placebo comparator | Placebo capsules with starch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of elderly women with sufficient vitamin D levels
Measured: four weeks after the intervention
Secondary outcomes (4)
number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein
Measured: four weeks after the intervention
number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein
Measured: four weeks after the intervention
number of elderly who have reduced plasma levels of malondialdehyde (MDA)
Measured: four weeks after the intervention
number of elderly that increased plasma antioxidant full capacity
Measured: four weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isa G M Cavalcante, DDS, Federal University of Paraíba
- Investigators
- Isa Gabriela M Cavalcante, DDS, Principal investigator, Federal University of ParaíbaMaria da Conceição R Gonçalves, PDH, Study director, Federal University of ParaíbaAlexandre S Silva, PHD, Study director, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222649
- Sponsor's protocol ID
- IGabriela
- Other IDs
- 0374/12
- Status last verified
- Aug 2014
- First submitted
- 15 Aug 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02222649
- Acronym / sponsor ID
- IGabriela
- Conditions
- Disorder of Aging
- Keywords
- Elderly, vitamin D insufficiency, High dose vitamin D3 supplementation, Polymorphism of the VDR gene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Group supplemented with high single dose of 200,000 IU of vitamin D3 (cholecalciferol) |
| placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules with starch |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the exclusion criteria
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferol, High doseHigh dose of 200,000 IU of cholecalciferol orally in a single dose | Dietary supplement | Vitamin D3 |
| PlaceboCapsules of starch, no therapeutic action | Dietary supplement | placebo group |
Primary outcome
number of elderly women with sufficient vitamin D levels
Time frame: four weeks after the intervention
4 secondary outcomes
number of elderly who have reduced serum levels of High-Sensitivity C-Reactive Protein
Time frame: four weeks after the intervention
number of elderly who have reduced serum levels of Alpha 1 Acid Glycoprotein
Time frame: four weeks after the intervention
number of elderly who have reduced plasma levels of malondialdehyde (MDA)
Time frame: four weeks after the intervention
number of elderly that increased plasma antioxidant full capacity
Time frame: four weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isa Gabriela M Cavalcante, DDS principal investigator
Federal University of Paraíba
Maria da Conceição R Gonçalves, PDH study director
Federal University of Paraíba
Alexandre S Silva, PHD study director
Federal University of Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Disorder of Aging, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isa Gabriela M Cavalcante, DDS (+55 (83) 9112 0584, isa.gabriela@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of elderly women with sufficient vitamin D levels (time frame: four weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.