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.

NCT03880734 | Completed Phase 2 DMC

• 1 other identifier: 10786
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma-COPD Overlap Syndrome

Outcome Measures

Primary Outcomes (9)

• 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.

  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 .

  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.

  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.

  8 month

• Forced Expiratory Flow25-75 (MEF25-75)

  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)

  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

• exercise tolerance measured by Oxygen saturation

  Oxygen saturation is defined as the oxygen content expressed as a percentage

  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.

  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.

  8 month

Secondary Outcomes (3)

• Anthropomertric measurement measured by BMI

  8 month

• Anthropomertric measurement measured by mid upper arm circumference (MUAC)

  8 month

• Anthropomertric measurement measured by waist hip ratio

  8 month

Study Arms (2)

study

EXPERIMENTAL

Vitamin D.Generic name-Cholecalciferol (40,000 IU).Dose- 80,000. Dosage-2 capsule/week for consecutive 26 weeks

Drug: Cholecalciferol

control

EXPERIMENTAL

Placebo oral capsule.Dose 80,000.Dosage-2 capsules for consecutive 26 weeks

Other: Placebo oral capsule

Interventions

Cholecalciferol DRUG

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)

Also known as: D-rise

study

Placebo oral capsule OTHER

ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)

Also known as: D-rise

control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Taskina Ali, MBBS, M.Phil

  Associate professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: All the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)' group

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 19, 2019
• Study Start: March 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: February 20, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-03

Locations

BA (1)