Chronic Obstructive Pulmonary DiseasePhase 2BSMMUNCT04011930
This Study Include Chronic Obstructive Pulmonary Disease(COPD) Patients . Patients Were Vitamin D Deficient Age Range 40 to 80 Years, Smokers Patients Were Advised to Take Either Placebo or Vitamin D3 . Antioxidant Enzymes Were Assessed at Baseline and at 26th Weeks.
A Phase 2 study testing cholecalciferol in people with Chronic Obstructive Pulmonary Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Vitamin D3 supplementation dose not increase plasma antioxidant enzymes level in COPD patients was the null hypothesis of the research. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- cholecalciferol
- 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 siteBangladesh
- Study dates
- 1 Mar 2019to 28 Feb 2020
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonologist diagnosed COPD patients
- Duration of COPD: 1-10 years
- Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml
- Age: >40years
- Sex: Male
- Socioeconomic status: Middle class
- smoker
Who cannot join
- With acute exacerbation of:
- any other pulmonary diseases like - bronchial asthma respiratory tract infection bronchiectasis pneumothorax pleural effusion tuberculosis pulmonary fibrosis pneumonectomy or pulmonary lobectomy any cardiac disease, like -
- unstable angina pectoris
- congestive heart failure
- myocardial infarction
- cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka, 1000
Billal Hossain, Masters, 01818568702
Golam Mostafa, Masters, 01972843555
About this study
Official title: Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients
Vitamin D3 supplementation dose not increase plasma antioxidant enzymes level in COPD patients was the null hypothesis of the research.
Read the detailed description
On the first day of enrollment, the objectives, nature, purpose and potential risk of all the procedures which are intended to be used for the study will be explained in detail to each COPD patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits he might obtain from this study. He will be encouraged for voluntary participation and will be allowed to withdraw himself from the study even after participation, whenever he feels uneasy. If he will agree to be enrolled in the study, an informed written consent will be taken in a prescribed form. Details family history, medical history and thorough physical examination of each patient will be done and all the information will be recorded in a standard data sheet. Then all the patients will be requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.
On that day, 16 ml of venous blood will be collected from antecubital vein of patient in different vacutainer tubes and will be taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml will be used for the estimation of serum vitamin D3 and rest will be preserved at -4˚C.
If the patient is with serum 25(OH)D <30 ng/ml (D3 deficiency) but >10 ng/ml (severe D3 deficient; for ethical purpose), then the serum parathormone (PTH), serum calcium, serum inorganic phosphate, serum alkaline phosphatase (ALP), serum glutamate-pyruvate transaminase (SGPT), fasting blood glucose, serum glycosylated hemoglobin HbA1C, serum cholesterol, serum high density lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), serum creatinine will be assessed from the preserved blood. After getting all the biochemical reports the final selection will be done, according to the inclusion and exclusion criteria. In addition serum level of Catalase and Superoxide dismutase will be done in the Department of Physiology, BSMMU. Then all the eligible patients will be randomly assigned to either 'study (A)' or 'control (B)' group. These data will be recorded as values of 'day 0' (A0, B0).
Subsequently a standard therapeutic treatment (according to Global initiative for chronic obstructive pulmonary disease guideline) will be prescribed (by the pulmonologist) to all the selected stable COPD patients of both groups. Proper education will be given about drug, method of taking medication and medication plan.
Along with the standard pharmacological treatment of COPD, all patients of both the groups will be advised to have sunlight exposure (within 11 am to 2 pm) only for 20 minutes daily and also to continue ad lib (according to their own choice) diet. In addition, oral vitamin D3 (80,000 IU per week) and placebo will be added to the treatment schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13 weeks.
Subsequently, all these patients (of both groups) will be cordially requested to attend the Department of Physiology on 13th week of their follow up, to reexamine the serum 25(OH)D and Calcium (to check the toxicity or deficiency). Then according to serum level of 25(OH)D and Ca, [vitamin D3 40,000 IU (1 capsule) per one to six weeks] (Vitamin D council 2019) will be again given to the 'Study' patients for further 13 weeks. On the other hand, if serum 25(OH)D is <10 ng/ml [severely deficient (vitamin D Council 2019)] of any 'control' patient, then he will be dropped out from the study (for ethical purpose) and a new COPD patient will be enrolled to fulfil the desired sample number. After that they will be cordially requested to visit again the Department of Physiology, BSMMU on '26th week' to reexamine all the study variables, and the data will be recorded as values of '26th week' (A2, B2).
During the entire study period (26 weeks), a good rapport will be kept by the researcher with every patient through taking time to time follow up over telephone and visiting patient's place with scheduled appointment to maintain a proper follow up at 2nd (at 13th week) and 3rd (at 26th week) visit of the study.
Any patient, who will fail to follow the study procedure exactly during study period, he will be dropped and a new one will be included to fulfil the desired total sample.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- cholecalciferol, Placebo oral capsule
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
Also called Vitamin D, Calcitriol
80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
Placebo oral capsuleDrug
Also called placebo treatment
80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental study | Active comparator | vitamin D Generic name -cholecalciferol (40,000IU)Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks.
Drug cholecalciferol- ingredients -cholecalciferol (40,000 IU) Microcrystalline cellulose(58.1 gm),hydroxy toluene (.2mg),magnesium stearate(3mg0,gelatin capsule shell(1mg)
other name D-rise Receives: Drug: cholecalciferol |
| Experimental control | Placebo comparator | Placebo oral capsule Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks
placebo oral capsule-ingredients-microcrystalline cellulose,butylated hydroxy toluene
,magnesium stearate
other name D-rise Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients
vitamin D3 supplementation will cause increased antioxidant enzymes level in vitamin D3 deficient COPD patients
Measured: 6 months vitamin D3 supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Mar 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible patients were randomly assigned to either study (A) control(B) group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Salma Anjum, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Taskina Ali, MBBS,M.Phil, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011930
- Sponsor's protocol ID
- 7102
- Acronym
- BSMMU
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients
- ClinicalTrials.gov ID
- NCT04011930
- Acronym / sponsor ID
- BSMMU / 7102
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 9 Jul 2019 (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 D3 supplementation dose not increase plasma antioxidant enzymes level in COPD patients was the null hypothesis of the research.
Detailed description
On the first day of enrollment, the objectives, nature, purpose and potential risk of all the procedures which are intended to be used for the study will be explained in detail to each COPD patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits he might obtain from this study. He will be encouraged for voluntary participation and will be allowed to withdraw himself from the study even after participation, whenever he feels uneasy. If he will agree to be enrolled in the study, an informed written consent will be taken in a prescribed form. Details family history, medical history and thorough physical examination of each patient will be done and all the information will be recorded in a standard data sheet. Then all the patients will be requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.
On that day, 16 ml of venous blood will be collected from antecubital vein of patient in different vacutainer tubes and will be taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml will be used for the estimation of serum vitamin D3 and rest will be preserved at -4˚C.
If the patient is with serum 25(OH)D <30 ng/ml (D3 deficiency) but >10 ng/ml (severe D3 deficient; for ethical purpose), then the serum parathormone (PTH), serum calcium, serum inorganic phosphate, serum alkaline phosphatase (ALP), serum glutamate-pyruvate transaminase (SGPT), fasting blood glucose, serum glycosylated hemoglobin HbA1C, serum cholesterol, serum high density lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), serum creatinine will be assessed from the preserved blood. After getting all the biochemical reports the final selection will be done, according to the inclusion and exclusion criteria. In addition serum level of Catalase and Superoxide dismutase will be done in the Department of Physiology, BSMMU. Then all the eligible patients will be randomly assigned to either 'study (A)' or 'control (B)' group. These data will be recorded as values of 'day 0' (A0, B0).
Subsequently a standard therapeutic treatment (according to Global initiative for chronic obstructive pulmonary disease guideline) will be prescribed (by the pulmonologist) to all the selected stable COPD patients of both groups. Proper education will be given about drug, method of taking medication and medication plan.
Along with the standard pharmacological treatment of COPD, all patients of both the groups will be advised to have sunlight exposure (within 11 am to 2 pm) only for 20 minutes daily and also to continue ad lib (according to their own choice) diet. In addition, oral vitamin D3 (80,000 IU per week) and placebo will be added to the treatment schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13 weeks.
Subsequently, all these patients (of both groups) will be cordially requested to attend the Department of Physiology on 13th week of their follow up, to reexamine the serum 25(OH)D and Calcium (to check the toxicity or deficiency). Then according to serum level of 25(OH)D and Ca, [vitamin D3 40,000 IU (1 capsule) per one to six weeks] (Vitamin D council 2019) will be again given to the 'Study' patients for further 13 weeks. On the other hand, if serum 25(OH)D is <10 ng/ml [severely deficient (vitamin D Council 2019)] of any 'control' patient, then he will be dropped out from the study (for ethical purpose) and a new COPD patient will be enrolled to fulfil the desired sample number. After that they will be cordially requested to visit again the Department of Physiology, BSMMU on '26th week' to reexamine all the study variables, and the data will be recorded as values of '26th week' (A2, B2).
During the entire study period (26 weeks), a good rapport will be kept by the researcher with every patient through taking time to time follow up over telephone and visiting patient's place with scheduled appointment to maintain a proper follow up at 2nd (at 13th week) and 3rd (at 26th week) visit of the study.
Any patient, who will fail to follow the study procedure exactly during study period, he will be dropped and a new one will be included to fulfil the desired total sample.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible patients were randomly assigned to either study (A) control(B) group
| Arm | Type | Receives |
|---|---|---|
| Experimental study | Active comparator | Drug: cholecalciferolvitamin D Generic name -cholecalciferol (40,000IU)Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks. Drug cholecalciferol- ingredients -cholecalciferol (40,000 IU) Microcrystalline cellulose(58.1 gm),hydroxy toluene (.2mg),magnesium stearate(3mg0,gelatin capsule shell(1mg) other name D-rise |
| Experimental control | Placebo comparator | Drug: Placebo oral capsulePlacebo oral capsule Dose-80,000 Dosage -2capsule/week for consecutive 26 weeks placebo oral capsule-ingredients-microcrystalline cellulose,butylated hydroxy toluene ,magnesium stearate other name D-rise |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pulmonologist diagnosed COPD patients
- Duration of COPD: 1-10 years
- Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml
- Age: >40years
- Sex: Male
Key exclusion criteria (6 listed)
- With acute exacerbation of:
- any other pulmonary diseases like - bronchial asthma respiratory tract infection bronchiectasis pneumothorax pleural effusion tuberculosis pulmonary fibrosis pneumonectomy or pulmonary lobectomy any cardiac disease, like -
- unstable angina pectoris
- congestive heart failure
- myocardial infarction
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 |
|---|---|---|
| cholecalciferolAlso: Vitamin D, Calcitriol80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks | Drug | Experimental study |
| Placebo oral capsuleAlso: placebo treatment80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks | Drug | Experimental control |
Primary outcome
Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients
Time frame: 6 months vitamin D3 supplementation
vitamin D3 supplementation will cause increased antioxidant enzymes level in vitamin D3 deficient COPD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- 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.
Taskina Ali, MBBS,M.Phil study director
Professor
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 cholecalciferol in people with Chronic Obstructive Pulmonary Disease, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 7 inclusion and 6 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 9 Jul 2019. 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 Bangladesh. 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 Taskina Ali, MBBS,M.Phil (01711848845, taskinadr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients (time frame: 6 months vitamin D3 supplementation). 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 9 Jul 2019.