Lupus Erythematosus, SystemicPhase 3NCT05326841
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
A Phase 3 study testing Vitamin D3 in people with Lupus Erythematosus, Systemic and Cholecalciferol Supplementation, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Lupus Erythematosus, Systemic, Cholecalciferol Supplementation, Disease Activity
- 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
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Oct 2021to 11 Jan 2022
- Phase
- Phase 3
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women subjects aged 18-60 years old with hypovitaminosis D
Who cannot join
- declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rscm Divisi Alergi Imunologi
Jakarta Pusat, Dki Jakarta, 10430
About this study
Official title: Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients
Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL
- Conditions
- Lupus Erythematosus, Systemic, Cholecalciferol Supplementation, Disease Activity, Quality of Life
- Being tested
- Vitamin D3
- Keywords
- lupus erythematosus systemic, cholecalciferol supplementation, Mex-SLEDAI score, Lupus QoL
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol
cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol group | Experimental | Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks Receives: Drug: Vitamin D3 |
| placebo group | Placebo comparator | Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of disease activity of participants at 12 weeks
level of disease activity from the participants at 12 weeks as respons from taking vitamin D and placebo by using Mex-sledai with score from 0 until 34. no activity or remission is 0-1, mild 2-5, moderate 6-9, severe 10-13, very severe more than and equally of 14.
Measured: level of vitamin d was measured at 12 weeks after the intervention
Level of quality of life of participants at 12 weeks
Level of lupus quality of life from the participants at 12 weeks as respsons from taking vitamin d and placebo by using Lupus QoL with score minimal 0, maximal 100. better quality of life > 75
Measured: level of quality of life was measured at 12 weeks after intervention
Secondary outcomes (1)
the level vitamin D of participants at 12 weeks
the level of vitamin D from participants at 12 weeks as respons from taking vitamin D3 and placebo
Measured: Level of vitamin D was measured at 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start3 Oct 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiblia, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326841
- Sponsor's protocol ID
- Cholecalciferol 5000 IU
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT05326841
- Acronym / sponsor ID
- Cholecalciferol 5000 IU
- Conditions
- Lupus Erythematosus, Systemic, Cholecalciferol Supplementation, Disease Activity, Quality of Life
- Keywords
- lupus erythematosus systemic, cholecalciferol supplementation, Mex-SLEDAI score, Lupus QoL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 14 Apr 2022 (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.
Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol group | Experimental | Drug: Vitamin D3Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks |
| placebo group | Placebo comparator | Drug: Vitamin D3Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women subjects aged 18-60 years old with hypovitaminosis D
Key exclusion criteria (1 listed)
- declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.
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: Cholecalciferolcholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks | Drug | Cholecalciferol group, placebo group |
Primary outcome
level of disease activity of participants at 12 weeks
Time frame: level of vitamin d was measured at 12 weeks after the intervention
level of disease activity from the participants at 12 weeks as respons from taking vitamin D and placebo by using Mex-sledai with score from 0 until 34. no activity or remission is 0-1, mild 2-5, moderate 6-9, severe 10-13, very severe more than and equally of 14.
Level of quality of life of participants at 12 weeks
Time frame: level of quality of life was measured at 12 weeks after intervention
Level of lupus quality of life from the participants at 12 weeks as respsons from taking vitamin d and placebo by using Lupus QoL with score minimal 0, maximal 100. better quality of life > 75
1 secondary outcome
the level vitamin D of participants at 12 weeks
Time frame: Level of vitamin D was measured at 12 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 in people with Lupus Erythematosus, Systemic and Cholecalciferol Supplementation, run by Dr Cipto Mangunkusumo General Hospital 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 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: finished, as of the sponsor's last update on 14 Apr 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of disease activity of participants at 12 weeks (time frame: level of vitamin d was measured at 12 weeks after the intervention). 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 14 Apr 2022.