A clinical trial to study the effect of vitamin D in improving the symptoms of heartburn and regurgitation in patients with Gastroesophageal reflux disease
- Conditions
- patients with gastro esophageal reflux disese and vitamin D deficiency
- Registration Number
- CTRI/2014/11/005183
- Lead Sponsor
- PGIMER
- Brief Summary
This study is a randomized, double blinded, placebo controlled cross over trial to know the effect of Vitamin D and calcium in patients with Gastro-esophageal reflux disease as assessed by esophageal manometry. The primary out come measures will be improvement in esophageal motor function and symptomatology. The secondary out come measures will be improvement in Quality of life of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 90
1.Patients diagnosed with Gastroesophageal reflux disease based on the clinical diagnostic criteria 2.Patients giving consent for their inclusion in the study 3.BMI < 30 kg/m².
1.Patient previously operated for GERD 2.Patients who have received mega doses (6,00,000 IU) of Vit D in the last 6 months 3.Patients having Peptic stricture, GOO, primary Systemic Sclerosis, Endoscopic Sclerotherapy, EVL, Esophageal varices 4.Women who are pregnant/lactating or planning conception; students; trainees; mentally retarded; institutionalised subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Esophageal motor function 4 weeks Improvement in symptomatology 4 weeks
- Secondary Outcome Measures
Name Time Method Improvement of quality of life Improvement in skeletal muscle function
Trial Locations
- Locations (1)
Dept of Gastroenterology
🇮🇳Chandigarh, CHANDIGARH, India
Dept of Gastroenterology🇮🇳Chandigarh, CHANDIGARH, IndiaUsha DuttaPrincipal investigator8198877022ushadutta@gmail.com