Effect of Vitamin D3 on Lung Function and Exercise Tolerance in COPD Patients

NCT03781895 | Completed Phase 1

• 1 other identifier: BSMMU/2016/11228
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality throughout the world which is a preventable as well as treatable disease. It has some important extra pulmonary effects which may contribute to the magnitude of the severity of this disease. Standard therapeutic treatment alone does not optimize its remedy. Vitamin D3 has been found to improve the physical efficiency of patients with various morbid disorders, including respiratory ailments. Hypothesis:Vitamin D3 administration in stable patients with moderate COPD improves lung function variables along with exercise tolerance. Objectives: To evaluate the effects of Vitamin D3 on lung functions and exercise tolerance in patients with stable moderate COPD. Methods: For this, a prospective interventional randomized double blinded study will be carried out on 46 vitamin D3 deficient (serum 25 dihidroxycholecalceferol less than 30 ng/ml), male, stable (diagnosed patient, who has not experienced any acute exacerbation , hospitalizations , urgent care visits, or changes in routine medication within 4 weeks prior to study), moderate (post bronchodilator FEV1/FVC\<0.70 of predicted value and FEV1=50 to 79% of predicted value) COPD patients (age ≥40 years), who will be selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and will be grouped as A (control) and B (study) groups, respectively. All the patients will be again designated as A0, A90 (without D3) and B0, B90 (with D3) for before and after 90 days of follow up. All the participants will be matched in terms of duration of COPD, history of smoking, occupation and socioeconomic status. Along with the standard pharmacological treatment of COPD, the patients of the 'Study group' will be prescribed for 80000 IU of oral vitamin D3 pre week for consecutive 3 months. Along with this, all patients both the groups will be advised to continue ad lib (according to their own choice) diet. At the very 1st day of the study, the lung functions will be assessed by measuring Forced vital capacity (FVC), Forced expiratory volume in one second (FEV1), Forced expiratory ratio (FEV1/FVC%), Peak expiratory flow rate (PEFR) and Forced mid expiratory flow of FVC(FEF25-75%), with a portable digital spirometer. In addition, exercise tolerance will be assessed by change in 6 Minute Walk Distance (6MWD) in 6 Minute Walk Test (6MWT). Changes in peripheral capillary oxygen saturation (SpO2) by Pulse Oximeter and degree of dyspnoea by Modified Borg Scale (MBS) will also be measured both before and after 6MWT to evaluate their change in both the groups. All these variables will be measured again among same 46 patient after 90 days standard pharmacological treatment of COPD with D3 intervention (B group) and also without D3 intervention (A group). For statistical analysis, Chi-square test, independent sample 't' test between two groups, paired Student's 't' test within two specific measurements of different durations of each group ,will be done. In the interpretation of results, ≤0.05 level of probability (p) will be accepted as significant.

Conditions

Stable COPD Patients

Keywords

COPD; VitaminD3; 6 Minute Walk Distance; Modified BORG scale

Outcome Measures

Primary Outcomes (12)

• Lung function (Spirometric variables) Forced Vital Capacity(FVC) will be changed

  Forced Vital Capacity 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. The FVC is commonly reduced in obstructive processes such as COPD.Increment of Forced Vital Capacity means improvement in outcome.

  After 90 days FVC will be measured again

• Lung function [ Lung function (Spirometric variables): Forced Expiratory Volume in 1st second(FEV1) will be changed

  Forced Expiratory Volume in 1st second 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 . Significance- This measurement is much more sensitive index of severity of the obstructive disease .In COPD ,FEV1 is reduced ,Increment of FEV1 indicates improvent in outcome

  After 90 days FEV1 will be measured again

• Lung function (Spirometric variables) Forced Expiratory Ratio [FEV1/FVC Ratio (%)] will be changed

  Forced Expiratory Ratio It is the ratio of FEV1 to FVC expressed in percentage. FEV1/FVC ratio = FEV1/FVC×100. It is about 70% or higher. Forced Expiratory Ratio is less than 70% in COPD patients.Increment of Forced Expiratory Ratio indicates improvement in outcome

  After 90 days FEV1/FVC Ratio will be measured again

• Lung function (Spirometric variables) Peak Expiratory Flow Rate [PEFR (L/min)] will be changed

  Peak Expiratory Flow Rate 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 Liter/second.

  After 90 days PEFR will be measured again

• Lung function (Spirometric variables) Forced Expiratory Flow in the middle of FVC [FEF 25-75 (Liter/Second) ] will be changed

  Forced Expiratory Flow in the middle of FVC Forced expiratory flow during the middle half of the FVC. Formerly it was called the maximal mid-expiratory flow (MMEF), expressed in liters/second Normal range in male : 1.5-4.5 Liter/second.Increment of Forced Expiratory Flow in the middle of FVC means improvement in outcome.

  After 90 days FEF 25-75 will be measured again

• Lung function (Spirometric variables) Maximum expiratory Flow rate at 25%of the FVC (MEF 75) will be changed

  Maximum expiratory Flow rate at 25%of the FVC (MEF 75) Maximum expiratory flow rate when 25% of the FVC remains in the lung to be exhaled and is equivalent to the FEF75 where 75% of the FVC has been exhaled. Expressed in liters/second. This is reduced in COPD. Increment in maximum expiratory flow at 25%of the FVC means improvement in outcome

  After 90 days MEF 75 will be measured again

• Lung function (Spirometric variables) Maximum expiratory Flow at 50%of the FVC(MEF50) will be changed

  Maximum expiratory Flow at 50%of the FVC(MEF50) Maximum expiratory flow rate when 50 % of the FVC remains in the lung to be exhaled and is equivalent to the FEF50 where 50% of the FVC has been exhaled. Expressed in liters/second. This is reduced in COPD. Increment in maximum expiratory flow at 50%of the FVC means improvement in outcome.

  After 90 days MEF 50 will be measured again

• Lung function (Spirometric variables) Maximum expiratory Flow at 75%of the FVC (MEF25)]will be changed

  Maximum expiratory Flow at 75%of the FVC (MEF25) Maximum expiratory flow rate when 75% of the FVC remains in the lung to be exhaled and is equivalent to the FEF25 where 25% of the FVC has been exhaled. Expressed in liters/second.This is reduced in COPD.Increment in maximum expiratory flow at 75%of the FVC means improvement in outcome

  After 90 days MEF25 will be measured again

• Exercise Tolerance [Oxygenation variables] Peripheral Capillary Oxygen saturation[SpO2 (%) ] will be changed

  Oxygenation variables Peripheral Capillary Oxygen saturation between 96% to 99% is normal.Peripheral Capillary Oxygen saturation between 96% to 99% means improved outcome

  After 90 days SpO2 will be measured

• Exercise Tolerance Exercise tolerance variables •Six Minute Walk Distance[6MWD (meter) ]will be changed

  Exercise tolerance variables • Six Minute Walk Distance \[6MWD (meter) \] minimum 350m in 6minute at a time(without taking any rest) is standard.The more the distance,the more the better outcome.

  After 90 days 6MWD will be measured

• Exercise Tolerance variables • Level of Dyspnea : Modified Borg Scale will be changed

  Level of Dyspnea : Modified Borg Scale If the dyspnea score decreases,it means better outcome If the dyspnea score increases,it means outcome is worse

  After 90 days level of Dyspnea will be measured

• Exercise Tolerance variables Level of fatigue: Modified Borg Scale will be changed

  Level of fatigue: Modified Borg Scale If the fatigue score decreases,it means better outcome, If the fatigue score increases,it means outcome is worse

  After 90 days level of fatigue will be measured

Study Arms (4)

A0

PLACEBO COMPARATOR

A0- On day 0,before intervention placebo, * Microcrystalline Cellulose (303.8gm) * Butylated Hydroxy Toluene (0.2mg) * Magnesium Stearate (3mg) * Gelatin Capsule Shell (1mg) weekly,orally,for 90days

Drug: Cholecalciferol

A90

PLACEBO COMPARATOR

A90- On day 90,after intervention placebo, * Microcrystalline Cellulose (303.8gm) * Butylated Hydroxy Toluene (0.2mg) * Magnesium Stearate (3mg) * Gelatin Capsule Shell (1mg) weekly,orally,for 90days

Drug: Cholecalciferol

B0

ACTIVE COMPARATOR

B0- On day 0,before intervention cholecalciferol, * Cholecalciferol (40,000IU) * Microcrystalline Cellulose (58.1 gm) * Butylated Hydroxy Toluene ( 0.2mg) * Magnesium Stearate (3mg) * Gelatin Capsule Shell (1mg) 80.000IU/week,orally,for 90 days

Drug: Cholecalciferol

B90

ACTIVE COMPARATOR

B90- On day 90,after intervention cholecalciferol, * Cholecalciferol (40,000IU) * Microcrystalline Cellulose (58.1 gm) * Butylated Hydroxy Toluene ( 0.2mg) * Magnesium Stearate (3mg) * Gelatin Capsule Shell (1mg) 80.000IU/week,orally,for 90 days

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

• Cholecalciferol (40,000IU), ,Microcrystalline Cellulose (58.1 gm), Butylated Hydroxy Toluene ( 0.2mg),Magnesium Stearate (3mg),Gelatin Capsule Shell (1mg)

Also known as: Microcrystalline Cellulose (58.1 gm), Butylated Hydroxy Toluene ( 0.2mg), Gelatin Capsule Shell (1mg), Magnesium Stearate (3mg)

A0; A90; B0; B90

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Socioeconomic status: Middle class
• Smoker
• Stable patients of COPD with \>1year duration
• Vitamin D3 deficient :
• Serum 25-hydroxycholecalciferol, \[25(OH)D\] level \<30ng/ml (Vitamin D Council 2017)

You may not qualify if:

• With acute exacerbation of any pulmonary diseases, as,
• with acute exacerbation of any cardiac disease, like -
• Uncontrolled systemic hypertension
• Chronic liver disease
• Malignancy
• Use of drugs known to affect vitamin D metabolism within 1 month prior to With biochemical evidence of -
• uncontrolled diabetes mellitus and
• renal insufficiency
• All the criteria mentioned above were scrutinized by taking history and clinical examination, except vitamin D3 deficiency, uncontrolled diabetes mellitus and renal insufficiency, which were diagnosed biochemically.

Sponsors & Collaborators

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

Study Sites (1)

Samia Hassan

Dhaka, 1213, Bangladesh

Location

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cholecalciferol; microcrystalline cellulose; Gelatin; stearic acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract 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; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Samia Hassan

  Bangabandhu Sheikh Mujib Medical University and National Institute of Disease of the Chest and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Prospective interventional randomized double blinded study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Two groups of Vitamin D3 deficient stable COPD patients were taken, Group A was given placebo along with standard therapeutic treatment and Group B was given Vitamin D3 along with standard therapeutic treatment

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 20, 2018
• Study Start: March 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)