Effect of Vitamin D3 on Lung Function and Exercise Tolerance in COPD Patients
Status:
Completed
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh