| CTRI Number |
CTRI/2014/11/005183 [Registered on: 07/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study the effect of vitamin D in improving the symptoms of heartburn and regurgitation in patients with Gastroesophageal reflux disease |
|
Scientific Title of Study
|
Effect of vitamin D and calcium supplementation on the esophageal motor function assessed by manometry in patients with Gastro esophageal reflux disease - A randomized double blinded placebo controlled cross over clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Dutta |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Dept of Gastro Enterology
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8198877022 |
| Fax |
|
| Email |
ushadutta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Dutta |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Dept of Gastro enterology
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8198877022 |
| Fax |
|
| Email |
ushadutta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kodati Rakesh |
| Designation |
Junior resident |
| Affiliation |
PGIMER |
| Address |
PGIMER
sector 12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9781994022 |
| Fax |
|
| Email |
kodatirakesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER departmental funds |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
sector 12
PGIMER
Chandigarh
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Usha Dutta |
Dept of Gastroenterology |
sector 12
PGIMER
chandigarh
Chandigarh
CHANDIGARH |
8198877022
ushadutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics comittee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with gastro esophageal reflux disese and vitamin D deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking placebo |
Identical looking placebo injection stat
Identical looking placebo calcium taken for 30 days |
| Intervention |
Vitamin D (Cholecalciferol)and oral calcium |
Injection Arachitol 600000 IU intramuscular stat
Oral Calcium citrate maleate 500 mg BD for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Esophageal motor function
Improvement in symptomatology |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement of quality of life
Improvement in skeletal muscle function |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|