To Study the role of vitamin D in asthma
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Registration Number
- CTRI/2022/11/047299
- Lead Sponsor
- Maulana azad medical college and associated Lok Nayak Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients with moderate asthma diagnosed according to latest GINA guidelines [2022] for at least 1 month
1.History of any chronic disease other than asthma (like cancer, liver disease, gall bladder disease, diabetes, uncontrolled hypertension and GI disorders affecting vitamin D absorption).
2.Respiratory tract infection within past 4 weeks.
3.Known allergy to vitamin D or taking vitamin D supplements.
4.Hypercalcemia ( >11mg/dl) or taking calcium supplements or history of recurrent kidney stones, Hyperparathyroidism ( >65pg/ml) and deranged serum electrolytes.
5.Use of concomitant medications that alter vitamin D metabolism (e.g phenytoin, corticosteroids) or absorption (e.g cholestyramine) or those that interfere with study endpoints.
6.History of cigarette smoking (more than 10 packs a year).
7.Deranged LFT (Liver enzymes >3 times upper limit of normal) or KFT (serum creatinine >1.2mg/dl)
8.Pregnant and nursing mothers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Asthma control test scores (ACT). <br/ ><br>2)Frequency of asthma exacerbation. <br/ ><br>Timepoint: 0, 6weeks, 12weeks, 18weeks, 20weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)Predictive percentage of forced expiratory volume in 1st second (FeV1), FEV1/FVC. <br/ ><br>2)Serum eosinophils levels. <br/ ><br>3)Quality of life (AQLQ- Asthma quality of life questionnaire). <br/ ><br>4)Percentage of patients requiring change in asthma treatment (step up / step down). <br/ ><br>5)No. of emergency visits and hospitalizations for asthma. <br/ ><br>6)Adverse events. <br/ ><br>Timepoint: 0, 6weeks, 12weeks, 18weeks, 20weeks