| CTRI Number |
CTRI/2021/04/032870 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To look for low magnesium levels among a group of subjects with features of alcohol dependence.
|
|
Scientific Title of Study
|
Prevalence of Hypomagnesemia among alcoholic patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angela Ann Jacob |
| Designation |
Student |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Kaanavil, Anandapply Post, Adoor
Pathanamthitta, Kerala
Pathanamthitta
KERALA
691525
India |
| Phone |
08281159722 |
| Fax |
|
| Email |
angelaannjacob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T George Koshy |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of General Medicine,
MOSC Medical College Kolenchery Ernakulam
KERALA
Ernakulam
KERALA
682311
India |
| Phone |
09633446430 |
| Fax |
|
| Email |
dsgkoshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T George Koshy |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of General Medicine
MOSC Medical College Kolenchery Ernakulam Kerala
Ernakulam
KERALA
682311
India |
| Phone |
09633446430 |
| Fax |
|
| Email |
dsgkoshy@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College, Kolenchery |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College |
| Address |
MOSC Medical College
Kolenchery Ernakulam
PIN:682311 |
| Type of Sponsor |
Private medical college |
|
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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 |
| Dr T George Koshy |
MOSC Medical College, Kolenchery |
Departement of General medicine,
Kolenchery
Ernakulam
KERALA |
09633446430
dsgkoshy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MOSC Medical College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E612||Magnesium deficiency, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
Inpatients admitted to the medicine wards at the study institution.
a)Age group: 18-85
b)According to the CAGE questionnaire |
|
| ExclusionCriteria |
| Details |
Presence of concomitant conditions causing magnesium depletion like:
1. Intestinal cause (malabsorption syndrome, endocrine & metabolic cause(hypothyroidism, aldosteronism)
2. Renal causes
3. History of intake of drug containing magnesium.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To make patients aware about magnesium deficiency and its effects and to give them adequate treatment.
|
4 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None planned for study |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dsgkoshy@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2054?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Alcoholic abuse is one of the most common health problems in India and is the third leading preventable cause of death followed by smoking and obesity. Due to alcoholism, a wide range of electrolyte and acid-base imbalance like hypomagnesaemia, hypophosphatemia, hypocalcaemia, hypokalaemia, metabolic acidosis and respiratory alkalosis can occur. Among those, hypomagnesaemia is the most common. Our aim of the study is to find prevalence of hypomagnesaemia among alcoholics and to give them adequate treatment. Better awareness of magnesium as well as other electrolytes like phosphorous, calcium, potassium deficiencies in chronic alcoholics can guide in imparting lifesaving treatment and lesser morbidity in such patients. So, by giving proper treatment to these patients can improve their health condition a lot in a better way. CAGE questionnaire will be given to all the inpatients admitted to medicine and psychiatry wards for categorizing them as alcoholic and non-alcoholics. it is a quick screening tool for checking the signs of possible alcohol dependency consisting of four questions which focuses on Cutting down, Annoyance by criticism, Guilty feeling and Eye Opener. Serum magnesium values of the alcoholic patients will be assessed and a value less than 1.6mg % will be considered as hypomagnesemia.
Inclusion Criteria: Inpatients admitted to medicine ward at the study institute. a) Age group: 18-84 b) According to CAGE Criteria
Exclusion Criteria: Presence of concomitant conditions causing magnesium depletion like 1. Intestinal cause (malabsorption syndrome, endocrine & metabolic cause [hypothyroidism, aldosteronism]) 2. Renal causes 3. History of intake of drug containing magnesium. Our sample size is n=224 and study design is Cross sectional study |