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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 : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr.Naznin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma-COPD Overlap Syndrome Drug: Cholecalciferol Other: Placebo oral capsule Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study
Vitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000. Dosage-2 capsule/week for consecutive 26 weeks
Drug: Cholecalciferol
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

Experimental: control
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




Primary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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.

  4. 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.


  5. Forced Expiratory Flow25-75 (MEF25-75) [ Time Frame: 8 month ]
    Forced expiratory flow during the middle half of the FVC.expressed in liters/second.

  6. 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.

  7. exercise tolerance measured by Oxygen saturation [ Time Frame: 8 month ]
    Oxygen saturation is defined as the oxygen content expressed as a percentage

  8. 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.

  9. 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.


Secondary Outcome Measures :
  1. 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

  2. Anthropomertric measurement measured by mid upper arm circumference (MUAC) [ Time Frame: 8 month ]
    measurement was done in cm

  3. Anthropomertric measurement measured by waist hip ratio [ Time Frame: 8 month ]
    Waist hip ratio was calculated as Weight in Cm/Height in cm



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Bangladesh
BSMMU
Dhaka, Bangladesh
Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Director: Taskina Ali, MBBS, M.Phil Associate professor
  Study Documents (Full-Text)

Documents provided by Dr.Naznin Sultana, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:

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Responsible Party: Dr.Naznin Sultana, principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03880734     History of Changes
Other Study ID Numbers: 10786
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Pulmonary Disease, Chronic Obstructive
Undifferentiated Connective Tissue Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Connective Tissue Diseases
Autoimmune Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents