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.
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|ClinicalTrials.gov Identifier: NCT03880734|
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma-COPD Overlap Syndrome||Drug: Cholecalciferol Other: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||All the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Vitamin D3 Supplementation on Lung Functions and Exercise Tolerance in D3 Deficient Asthma COPD Overlap (ACO) Patients|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||November 1, 2018|
|Actual Study Completion Date :||February 20, 2019|
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 Name: D-rise
Placebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks
Other: Placebo oral capsule
ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
Other Name: D-rise
- 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.
- 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
- Anthropomertric measurement measured by mid upper arm circumference (MUAC) [ Time Frame: 8 month ]measurement was done in cm
- Anthropomertric measurement measured by waist hip ratio [ Time Frame: 8 month ]Waist hip ratio was calculated as Weight in Cm/Height in cm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880734
|Study Director:||Taskina Ali, MBBS, M.Phil||Associate professor|