Asthma-COPD Overlap SyndromePhase 2NCT03880734
This Study Include Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap Patients.Patients Were Vitamin D Deficient.Age Range 40-70 Years, Smokers.Patients Were Advised to Take Either Placebo or Vitamin D3.Lung Functions and Exercise Tolerance Were Assessed at Baseline and at 26th Weeks.
A Phase 2 study testing Cholecalciferol in people with Asthma-COPD Overlap Syndrome, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Vitamin D3 supplementation doen not change lung functions and exercise tolerance in vitamin D3 deficient ACO patient was the null hypothesis of the research. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma-COPD Overlap Syndrome
- 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
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Mar 2018to 20 Feb 2019
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pulmonologist diagnosed patient of ACO
- Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml
- Age: 40-70 years
- Sex: Male
- Socioeconomic status: middle class
- Smoker
Show all 20Show fewer
- Anthropometric status:
- BMI=18.6-24.9 kg mid upper arm circumference>25.1 cm waist-hip ratio<0.89
- Serum parathormone: 10-65 pg/ml
- Serum Ca2+: 8.5-10.5 mg/dl
- Serum PO43: 2.3-4.7 mg/dl
- Serum alkaline phosphatase: 30-120 U/L
- SGPT: <50 U/L
- Serum creatinine: 0.7-1.3 mg/dl
- Fasting Blood Sugar (FBS): 3.5-6.1 mmol/L
- Serum HbA1c: 4.5-6.3 %
- Serum cholesterol: <200 mg/dl
- Serum HDL: >40 mg/dl,
- Serum LDL: <130 mg/dl
- Serum TG: <150 mg/dl
Who cannot join
- With history of:
- any other pulmonary diseases, as, chronic obstructive pulmonary disease bronchial asthma respiratory tract infection bronchiectasis pleural effusion tuberculosis interstitial lung disease pneumonectomy or pulmonary lobectomy
- any cardiac disease, like - unstable angina pectoris congestive heart failure myocardial infarction cardiac arrhythmia
- systemic hypertension
- any liver disease
- any malignancy
- use of any drugs known to affect vitamin D metabolism within 1 month prior to study, as, antiepileptics (Phenytoin, Carbamazepine) antibiotics (Clotrimazole, Rifampicin) antihypertensives (Nifedipine, Spironolactone) antiretroviral drugs (Ritonavir, Saquinavir) endocrine drugs (Cyproterone acetate) glucocorticoids bisphosphonate calcium supplement
- With biochemical evidence of diabetes mellitus renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients
Vitamin D3 supplementation doen not change lung functions and exercise tolerance in vitamin D3 deficient ACO patient 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 used for the study was explained in detail to each ACO patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits the participants might obtain from this study. The participants was encouraged for voluntary participation and was allowed to withdraw from the study even after participation, whenever participant felt uneasy. If the participant was agreed to be enrolled in the study, an informed written consent was taken in a prescribed form . Then all the patients were requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.
On that day, 10 ml of venous blood was collected from antecubital vein of patient in different vacutainer tubes and was taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml was for the estimation of serum vitamin D3 and rest was preserved at -4˚C.
If the patient was with D3 deficiency [Serum 25(OH)D <30 ng/ml], then the serum creatinine, serum HbA1C, serum parathormone (PTH), serum calcium (Ca2+), serum phosphate (PO43-), serum alkaline phosphatase (ALP), serum glutamate pyruvate transaminase (SGPT) serum cholesterol, serum High Density Lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), were assessed from the preserved blood. After getting all the biochemical reports the final selection was done, according to the inclusion and exclusion criteria.
Then all the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group.Then all the study variables of all the subjects of both the groups were assessed. These data were recorded as values of 'day 1' (A1, B1).
Subsequently a standard therapeutic treatment [according to Global Initiative for Chronic Obstructive Lung Diseases (GOLD) guideline] were prescribed (by the pulmonologist) to all the selected stable ACO patients of both groups. Proper education were given about drug, method of taking medication and medication plan plan, such as, training for Metered Dose Inhaler (MDI) use for 7 days.
Along with the standard pharmacological treatment of ACO, all patients of both the groups were 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 were added to the treatment schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13 weeks.
Subsequently, all these patients (of both groups) were cordially requested to attend the Department of Physiology on 13th week of their follow up, to reexamine all the study variables along with serum 25(OH)D and Ca (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] (American Vitamin D council 2018) was again given to the 'Study' patients for further 13 weeks. On the other hand, if serum 25(OH)D was <10 ng/ml [severely deficient (vitamin D Council 2018)] of any 'control' patient, then that participant was dropped out from the study (for ethical purpose) and a new ACO patient was enrolled to fulfil the desired sample number. After that they were cordially requested to visit again the Department of Physiology, BSMMU on '26th week' to reexamine all the study variables, and the data was recorded as values of '26th week' (A2, B2).
During the entire study period (26 weeks), a good rapport was 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.
- Conditions
- Asthma-COPD Overlap Syndrome
- Being tested
- Cholecalciferol, Placebo oral capsule
- Medical subject headings
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called D-rise
ingredients-Cholecalciferol (40,000 IU),Microcrystalline Cellulose (58.1 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
Placebo oral capsuleOther
Also called D-rise
ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Vitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000. Dosage-2 capsule/week for consecutive 26 weeks Receives: Drug: Cholecalciferol |
| control | Experimental | Placebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks Receives: Other: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function status measured by Forced vital capacity (FVC)
It is the volume of air that can be expired as forcefully and rapidly as possible after maximal inspiration.In adult male it is about 4.6 liters.
Measured: 8 month
Lung function status measured by Forced expiratory volume in 1st second (FEV1) Mid Expiratory Flow 75% (MEF75%),Mid Expiratory Flow50% (MEF50%), Mid Expiratory Flow 25%(MEF25%)
When a person inspires maximally and exhales forcefully, then the volume, which is exhaled in 1st second is known as 'Forced Expiratory volume in 1st second'. It is normally 80% of forced vital capacity .
Measured: 8 month
Lung function status measured by Ratio of Forced expiratory volume in 1st second and Forced vital capacity (FEV1 /FVC ratio)
It is the ratio of FEV1 to FVC expressed in percentage. FEV1/FVC ratio = FEV1/FVC×100. It is about 70% or higher.
Measured: 8 month
Lung function status measured by Peak expiratory flow rate (PEER)
It is the maximum expiratory rate, beyond which the flow cannot be increased even with greatly increased additional force.
In adult it is about 400-700 L/minute.
Measured: 8 month
Forced Expiratory Flow25-75 (MEF25-75)
Forced expiratory flow during the middle half of the FVC.expressed in liters/second.
Measured: 8 month
exercise tolerance measured by 6 Minute Walk Distancd (6MWD)
It is the distance that a person can quickly walk on a flat, hard surface in a period of 6 minutes.expressed in meters.
Measured: 8 month
exercise tolerance measured by Oxygen saturation
Oxygen saturation is defined as the oxygen content expressed as a percentage
Measured: 8 month
exercise tolerance measured by Level of dyspnea
a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity'.evaluated by BORG scale.
Measured: 8 month
Exercise tolerance measured by level of fatigue
a subjective, unpleasant symptom which incorporates total body feelings ranging from tiredness to exhaustion, creating an unrelenting overall condition which interferes with individuals' .evaluated by BORG scale.
Measured: 8 month
Secondary outcomes (3)
Anthropomertric measurement measured by BMI
Body mass index (BMI) of each subject was calculated from the measured weight and height. Expressed in kg/m2
Measured: 8 month
Anthropomertric measurement measured by mid upper arm circumference (MUAC)
measurement was done in cm
Measured: 8 month
Anthropomertric measurement measured by waist hip ratio
Waist hip ratio was calculated as Weight in Cm/Height in cm
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Mar 2018
- Primary completion1 Nov 2018
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma-COPD Overlap SyndromeStudies 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 the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Naznin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Taskina Ali, MBBS, M.Phil, Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880734
- Sponsor's protocol ID
- 10786
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 21 Jun 2019
- 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 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients
- ClinicalTrials.gov ID
- NCT03880734
- Acronym / sponsor ID
- 10786
- Conditions
- Asthma-COPD Overlap Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 19 Mar 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 doen not change lung functions and exercise tolerance in vitamin D3 deficient ACO patient 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 used for the study was explained in detail to each ACO patients (diagnosed by pulmonologist), with a cordial attitude giving emphasis on the benefits the participants might obtain from this study. The participants was encouraged for voluntary participation and was allowed to withdraw from the study even after participation, whenever participant felt uneasy. If the participant was agreed to be enrolled in the study, an informed written consent was taken in a prescribed form . Then all the patients were requested to attend the Department of Physiology at 8:30 am (after overnight fasting) on the examination day.
On that day, 10 ml of venous blood was collected from antecubital vein of patient in different vacutainer tubes and was taken to the laboratory of Department of Biochemistry and Molecular Biology as soon as possible, where 3 ml was for the estimation of serum vitamin D3 and rest was preserved at -4˚C.
If the patient was with D3 deficiency [Serum 25(OH)D <30 ng/ml], then the serum creatinine, serum HbA1C, serum parathormone (PTH), serum calcium (Ca2+), serum phosphate (PO43-), serum alkaline phosphatase (ALP), serum glutamate pyruvate transaminase (SGPT) serum cholesterol, serum High Density Lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride (TG), were assessed from the preserved blood. After getting all the biochemical reports the final selection was done, according to the inclusion and exclusion criteria.
Then all the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group.Then all the study variables of all the subjects of both the groups were assessed. These data were recorded as values of 'day 1' (A1, B1).
Subsequently a standard therapeutic treatment [according to Global Initiative for Chronic Obstructive Lung Diseases (GOLD) guideline] were prescribed (by the pulmonologist) to all the selected stable ACO patients of both groups. Proper education were given about drug, method of taking medication and medication plan plan, such as, training for Metered Dose Inhaler (MDI) use for 7 days.
Along with the standard pharmacological treatment of ACO, all patients of both the groups were 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 were added to the treatment schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13 weeks.
Subsequently, all these patients (of both groups) were cordially requested to attend the Department of Physiology on 13th week of their follow up, to reexamine all the study variables along with serum 25(OH)D and Ca (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] (American Vitamin D council 2018) was again given to the 'Study' patients for further 13 weeks. On the other hand, if serum 25(OH)D was <10 ng/ml [severely deficient (vitamin D Council 2018)] of any 'control' patient, then that participant was dropped out from the study (for ethical purpose) and a new ACO patient was enrolled to fulfil the desired sample number. After that they were cordially requested to visit again the Department of Physiology, BSMMU on '26th week' to reexamine all the study variables, and the data was recorded as values of '26th week' (A2, B2).
During the entire study period (26 weeks), a good rapport was 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: CholecalciferolVitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000. Dosage-2 capsule/week for consecutive 26 weeks |
| control | Experimental | Other: Placebo oral capsulePlacebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pulmonologist diagnosed patient of ACO
- Vitamin D3 deficient : Serum 25(OH)D <30 ng/ml
- Age: 40-70 years
- Sex: Male
- Socioeconomic status: middle class
Key exclusion criteria (8 listed)
- With history of:
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: D-riseingredients-Cholecalciferol (40,000 IU),Microcrystalline Cellulose (58.1 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg) | Drug | study |
| Placebo oral capsuleAlso: D-riseingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg) | Other | control |
Primary outcome
Lung function status measured by Forced vital capacity (FVC)
Time frame: 8 month
It is the volume of air that can be expired as forcefully and rapidly as possible after maximal inspiration.In adult male it is about 4.6 liters.
Lung function status measured by Forced expiratory volume in 1st second (FEV1) Mid Expiratory Flow 75% (MEF75%),Mid Expiratory Flow50% (MEF50%), Mid Expiratory Flow 25%(MEF25%)
Time frame: 8 month
When a person inspires maximally and exhales forcefully, then the volume, which is exhaled in 1st second is known as 'Forced Expiratory volume in 1st second'. It is normally 80% of forced vital capacity .
Lung function status measured by Ratio of Forced expiratory volume in 1st second and Forced vital capacity (FEV1 /FVC ratio)
Time frame: 8 month
It is the ratio of FEV1 to FVC expressed in percentage. FEV1/FVC ratio = FEV1/FVC×100. It is about 70% or higher.
Lung function status measured by Peak expiratory flow rate (PEER)
Time frame: 8 month
It is the maximum expiratory rate, beyond which the flow cannot be increased even with greatly increased additional force. In adult it is about 400-700 L/minute.
Forced Expiratory Flow25-75 (MEF25-75)
Time frame: 8 month
Forced expiratory flow during the middle half of the FVC.expressed in liters/second.
exercise tolerance measured by 6 Minute Walk Distancd (6MWD)
Time frame: 8 month
It is the distance that a person can quickly walk on a flat, hard surface in a period of 6 minutes.expressed in meters.
exercise tolerance measured by Oxygen saturation
Time frame: 8 month
Oxygen saturation is defined as the oxygen content expressed as a percentage
exercise tolerance measured by Level of dyspnea
Time frame: 8 month
a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity'.evaluated by BORG scale.
Exercise tolerance measured by level of fatigue
Time frame: 8 month
a subjective, unpleasant symptom which incorporates total body feelings ranging from tiredness to exhaustion, creating an unrelenting overall condition which interferes with individuals' .evaluated by BORG scale.
3 secondary outcomes
Anthropomertric measurement measured by BMI
Time frame: 8 month
Anthropomertric measurement measured by mid upper arm circumference (MUAC)
Time frame: 8 month
Anthropomertric measurement measured by waist hip ratio
Time frame: 8 month
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 21 Jun 2019.
Related trials for Asthma-COPD Overlap Syndrome
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Effect of Video Game-Based Breathing Exercises on Respiratory Dysfunction in ACOS
Asthma-COPD Overlap Syndrome, Pulmonary Rehabilitation
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
Associate 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 Asthma-COPD Overlap Syndrome, 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 20 inclusion and 8 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 21 Jun 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. 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?
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?
Lung function status measured by Forced vital capacity (FVC) (time frame: 8 month). The study lists 9 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 21 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.