Frail Elderly SyndromePhase 4NCT03292744
Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly
A Phase 4 study testing Alfacalcidol in people with Frail Elderly Syndrome and Elderly Infection, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Elderly Infection
- What is being tested?
- Alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jan 2017to 15 Dec 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly age more than 60
- Willing to join research
Who cannot join
- In acute infection
- Using NSAID or steroid
- Liver failure
- Hypercalcemia
Trial locations and contacts
1 site in 1 country.
Aulia Rizka, MD contact
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo National Hospital
Jakarta
Aulia Rizka, MD, +628125265600, dr.auliarizka@yahoo.co.id
About this study
Official title: Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.
Read the detailed description
This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.
- Conditions
- Frail Elderly Syndrome, Elderly Infection
- Being tested
- Alfacalcidol
- Keywords
- immunosenescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfacalcidolDrug
Also called 1 alpha hydroxy cholecalciferol
alfacalcidol 0,5 mcg
| Study group | Role | What they receive |
|---|---|---|
| Alfacalcidol | Experimental | Alfacalcidol 0,5 mcg once daily for 90 days Receives: Drug: Alfacalcidol |
| Placebo | Placebo comparator | Amylum same capsule form, weight and colour with treatment arm Receives: Drug: Alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory tract infection incidence
incidence of URTI
Measured: 90 days
lower respiratory tract infection incidence
incidence of LRTI
Measured: 90 days
Secondary outcomes (3)
inflammatory markers
IL6, IL10 and IFN gamma in PBMC
Measured: day 90
T cell subset
CD4/CD8 ratio, CD8+ CD28- percentage
Measured: day 90
antibiotic use
any antibiotic prescribed by physician
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start10 Jan 2017
- Primary completion10 Oct 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aulia Rizka, Universitas Indonesia
- Investigators
- Aulia Rizka, MD, Principal investigator, Universitas Indonesia / Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292744
- Sponsor's protocol ID
- VitaminDIndonesia
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
- ClinicalTrials.gov ID
- NCT03292744
- Acronym / sponsor ID
- VitaminDIndonesia
- Conditions
- Frail Elderly Syndrome, Elderly Infection
- Keywords
- immunosenescence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 10 Oct 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 26 Sep 2017 (actual)
- 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.
Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.
Detailed description
This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfacalcidol | Experimental | Drug: AlfacalcidolAlfacalcidol 0,5 mcg once daily for 90 days |
| Placebo | Placebo comparator | Drug: AlfacalcidolAmylum same capsule form, weight and colour with treatment arm |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly age more than 60
- Willing to join research
Key exclusion criteria (4 listed)
- In acute infection
- Using NSAID or steroid
- Liver failure
- Hypercalcemia
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 |
|---|---|---|
| AlfacalcidolAlso: 1 alpha hydroxy cholecalciferolalfacalcidol 0,5 mcg | Drug | Alfacalcidol, Placebo |
Primary outcome
upper respiratory tract infection incidence
Time frame: 90 days
incidence of URTI
lower respiratory tract infection incidence
Time frame: 90 days
incidence of LRTI
3 secondary outcomes
inflammatory markers
Time frame: day 90
T cell subset
Time frame: day 90
antibiotic use
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Aulia Rizka, MD contact
Aulia Rizka, MD principal investigator
Universitas Indonesia / Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidol in people with Frail Elderly Syndrome and Elderly Infection, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 4 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 26 Sep 2017. 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 Indonesia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Aulia Rizka, MD (+628125265600, dr.auliarizka@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper respiratory tract infection incidence (time frame: 90 days). The study lists 2 primary outcomes in all. 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 26 Sep 2017.