- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880734
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.
Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- BSMMU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: study
Vitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000.
Dosage-2 capsule/week for consecutive 26 weeks
|
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)
Other Names:
|
EXPERIMENTAL: control
Placebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks
|
ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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%)
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 .
|
8 month
|
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.
|
8 month
|
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. |
8 month
|
Forced Expiratory Flow25-75 (MEF25-75)
Time Frame: 8 month
|
Forced expiratory flow during the middle half of the FVC.expressed in liters/second.
|
8 month
|
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.
|
8 month
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exercise tolerance measured by Oxygen saturation
Time Frame: 8 month
|
Oxygen saturation is defined as the oxygen content expressed as a percentage
|
8 month
|
exercise tolerance measured by Level of dyspnea
Time Frame: 8 month
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a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity'.evaluated by BORG scale.
|
8 month
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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.
|
8 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropomertric measurement measured by BMI
Time Frame: 8 month
|
Body mass index (BMI) of each subject was calculated from the measured weight and height.
Expressed in kg/m2
|
8 month
|
Anthropomertric measurement measured by mid upper arm circumference (MUAC)
Time Frame: 8 month
|
measurement was done in cm
|
8 month
|
Anthropomertric measurement measured by waist hip ratio
Time Frame: 8 month
|
Waist hip ratio was calculated as Weight in Cm/Height in cm
|
8 month
|
Collaborators and Investigators
Investigators
- Study Director: Taskina Ali, MBBS, M.Phil, Associate Professor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- 10786 (Fred Hutch/University of Washington Cancer Consortium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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