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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. (BSMMU)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
cholecalciferol
Placebo oral capsule
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • BSMMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental study

Experimental control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 4, 2019
Last Updated
July 4, 2019
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04011930
Brief Title
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.
Acronym
BSMMU
Official Title
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Level in Vitamin D3 Deficient COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All eligible patients were randomly assigned to either study (A) control(B) group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental study
Arm Type
Active Comparator
Arm Description
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
Arm Title
Experimental control
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
Vitamin D, Calcitriol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
placebo treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient COPD patients
Description
vitamin D3 supplementation will cause increased antioxidant enzymes level in vitamin D3 deficient COPD patients
Time Frame
6 months vitamin D3 supplementation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taskina Ali, MBBS,M.Phil
Phone
01711848845
Email
taskinadr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salma Anjum, MBBS
Phone
01768033336
Email
salma.fmc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taskina Ali, MBBS,M.Phil
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
BSMMU
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Billal Hossain, Masters
Phone
01818568702
First Name & Middle Initial & Last Name & Degree
Golam Mostafa, Masters
Phone
01972843555

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

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