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.
Condition: Asthma-COPD Overlap Syndrome
MeSH terms: Asthma; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      On the first day of enrollment, the objectives, nature, purpose and potential risk of all the
      procedures used for the study was explained in detail to each ACO patients (diagnosed by
      pulmonologist), with a cordial attitude giving emphasis on the benefits the participants
      might obtain from this study. The participants was encouraged for voluntary participation and
      was allowed to withdraw from the study even after participation, whenever participant felt
      uneasy. If the participant was agreed to be enrolled in the study, an informed written
      consent was taken in a prescribed form . Then all the patients were requested to attend the
      Department of Physiology at 8:30 am (after overnight fasting) on the examination day.

      On that day, 10 ml of venous blood was collected from antecubital vein of patient in
      different vacutainer tubes and was taken to the laboratory of Department of Biochemistry and
      Molecular Biology as soon as possible, where 3 ml was for the estimation of serum vitamin D3
      and rest was preserved at -4˚C.

      If the patient was with D3 deficiency [Serum 25(OH)D <30 ng/ml], then the serum creatinine,
      serum HbA1C, serum parathormone (PTH), serum calcium (Ca2+), serum phosphate (PO43-), serum
      alkaline phosphatase (ALP), serum glutamate pyruvate transaminase (SGPT) serum cholesterol,
      serum High Density Lipoprotein (HDL), serum low density lipoprotein (LDL), serum triglyceride
      (TG), were assessed from the preserved blood. After getting all the biochemical reports the
      final selection was done, according to the inclusion and exclusion criteria.

      Then all the eligible patients were randomly assigned to either 'Study (A)' or 'Control (B)'
      group.Then all the study variables of all the subjects of both the groups were assessed.
      These data were recorded as values of 'day 1' (A1, B1).

      Subsequently a standard therapeutic treatment [according to Global Initiative for Chronic
      Obstructive Lung Diseases (GOLD) guideline] were prescribed (by the pulmonologist) to all the
      selected stable ACO patients of both groups. Proper education were given about drug, method
      of taking medication and medication plan plan, such as, training for Metered Dose Inhaler
      (MDI) use for 7 days.

      Along with the standard pharmacological treatment of ACO, all patients of both the groups
      were advised to have sunlight exposure (within 11 am to 2 pm) only for 20 minutes daily and
      also to continue ad lib (according to their own choice) diet.

      In addition, oral vitamin D3 (80,000 IU per week) and placebo were added to the treatment
      schedule of the 'Study' patients and 'Control' patients, respectively, for consecutive 13
      weeks.

      Subsequently, all these patients (of both groups) were cordially requested to attend the
      Department of Physiology on 13th week of their follow up, to reexamine all the study
      variables along with serum 25(OH)D and Ca (to check the toxicity or deficiency). Then
      according to serum level of 25(OH)D and Ca,[vitamin D3 40,000 IU (1 capsule) per one to six
      weeks] (American Vitamin D council 2018) was again given to the 'Study' patients for further
      13 weeks. On the other hand, if serum 25(OH)D was <10 ng/ml [severely deficient (vitamin D
      Council 2018)] of any 'control' patient, then that participant was dropped out from the study
      (for ethical purpose) and a new ACO patient was enrolled to fulfil the desired sample number.
      After that they were cordially requested to visit again the Department of Physiology, BSMMU
      on '26th week' to reexamine all the study variables, and the data was recorded as values of
      '26th week' (A2, B2).

      During the entire study period (26 weeks), a good rapport was kept by the researcher with
      every patient through taking time to time follow up over telephone and visiting patient's
      place with scheduled appointment to maintain a proper follow up at 2nd (at 13th week) and 3rd
      (at 26th week) visit of the study.
    

Intervention name(s): Cholecalciferol; Placebo oral capsule
Intervention type(s): Drug; Other
Intervention description(s): 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); ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
Other intervention name(s): D-rise; D-rise
Intervention MeSH terms: Cholecalciferol; Vitamin D
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