Status:
COMPLETED
Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma Chronic Obstructive Pulmonary Disease(COPD) Overlap Patients
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Asthma-COPD Overlap Syndrome
Vitamin D Deficiency
Eligibility:
MALE
40-80 years
Phase:
NA
Brief Summary
Title:Impact of vitamin D administration on cardiac autonomic tone in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap patients: A blinded randomized control trial. Background: Respiratory...
Detailed Description
Previous studies reported earlier age of onset, symptom with longer duration, more exacerbation and devoid of adequate health care in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap (ACO) ...
Eligibility Criteria
Inclusion
- • 40-80 years of age
- Male
- Middle class of socioeconomic condition:.
- Stable patients of Asthma COPD Overlap (ACO) with \>4 years of disease duration.
- Vitamin D deficient (Serum 25-hydroxycholecalciferol, 25(OH)D level \< 30 ng/ml).
- Normal serum Ca+and inorganic phosphate level.
- Hypertension with ACO.
- Diabetes with ACO
Exclusion
- Unstable patients with ACO (patients with exacerbation and medication changes in the past 30 days)
- With acute exacerbation of any pulmonary diseases, such as,
- Bronchial asthma
- Acute respiratory tract infection
- Current tuberculosis
- Pleural effusion
- Emphysematous bullae
- Interstitial lung disease
- Pneumonectomy or pulmonary lobectomy
- Pulmonary fibrosis.
- With acute exacerbation of any cardiac disease, like -
- Unstable angina pectoris
- Congestive heart failure
- Myocardial infarction
- Cardiac arrhythmia
- Rheumatoid arthritis.
- Inflammatory bowel disease.
- Chronic Renal Failure.
- Systemic lupus erythromatosIs.
- Musculoskeletal diseases.
- Any malignancy
- Systemic hypertension
- Use of drugs known to affect Central Nervous System (CNS) and vitamin D metabolism within 1 month prior to study, as,
- Antiepileptics (Phenytoin, Carbamazepine)
- Antibiotics (Clotrimazole, Rifampicin)
- Antihypertensives (Nifedipine, Spironolactone)
- Antiretroviral drugs (Ritononavir, Saquinavir)
- Endocrine drugs (Cyproterone acetate)
- Glucocorticoids
- Bisphosphonate
- Calcium supplement
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03773809
Start Date
August 1 2017
End Date
August 31 2018
Last Update
December 12 2018
Active Locations (1)
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1
Dr Sultana Ferdousi
Dhaka, Bangladesh, 1200