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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Taskina Ali, MBBS,M.Phil contact

01711848845

taskinadr@gmail.com

Salma Anjum, MBBS contact

01768033336

salma.fmc@gmail.com

Bangladesh1 site, 1 recruiting
  • BSMMU

    Dhaka, 1000

    Billal Hossain, Masters, 01818568702

    Golam Mostafa, Masters, 01972843555

    Recruiting

Other trials in Bangladesh

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.

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 groups in NCT04011930
Study groupRoleWhat they receive
Experimental studyActive comparatorvitamin 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 controlPlacebo comparatorPlacebo 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.

  1. 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.

  1. First posted9 Jul 2019
  2. Study start1 Mar 2019
  3. Primary completion28 Feb 2020 (estimated)
  4. Study completion28 Feb 2020 (estimated)

Resources

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)
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

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.

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