| CTRI Number |
CTRI/2024/09/074357 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [descriptive research design] |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between anemia and BMI. |
|
Scientific Title of Study
|
Occurrence of Iron Deficiency Anemia and correlate anemia with body mass index of young adults in a Nursing college at Mangaluru |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daisy PJ |
| Designation |
PG student |
| Affiliation |
Father Muller College of Nursing, Mangaluru |
| Address |
Father Muller College of Nursing,1st year MSC Nursing student,kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9188279221 |
| Fax |
|
| Email |
srroshninicss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shycil Mathew |
| Designation |
Associate professor |
| Affiliation |
Father Muller College of Nursing Kankanady |
| Address |
Father Muller College of Nursing, Department of Community Health Nursing, Kankanady,Dakshina Kannada Mangaluru,Karnataka,India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9538812499 |
| Fax |
|
| Email |
shycilmathew@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Priya Sweety Pereira |
| Designation |
Associate Professor |
| Affiliation |
Father muller college of Nursing |
| Address |
Father Muller College of Nursing, Department of Community Health Nursing, Kankanady,Dakshina Kannada Mangaluru,Karnataka,India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9964071152 |
| Fax |
|
| Email |
prdsouza86@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Center, Father Muller Charitable Institutions, Father Muller Road, Kankanady, Mangaluru, 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Center |
| Address |
Father Muller Charitable Institution, Kankanady, Mangalore, Dakshina Kannada, Karnataka, India -575002 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Daisy P J |
Father Muller College of Nursing, 1st MSc Nursing student, Community Health Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India- 575002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shycil Mathew |
Father Muller College of Nursing |
Father Muller College of Nursing, Kankanady, Mangalore, Dakshina Kannada, Karnataka, India -575002
Dakshina Kannada
KARNATAKA |
9538812499
shycilmathew@fathermuller.in |
| Dr Shycil Mathew |
Father Muller College of Nursing |
Department:Nursing
Division/room:Lecture hall -1,2,3,4 BSC (N),GNM-Lecture Hall(5,6)PBBSC(N) Lecture class-7,8
Dakshina Kannada
KARNATAKA |
9538812499
shycilmathew@fathermuller.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nursing students, females between the age group of 17-24 years. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Hemoglobin Test.
2.Serum Ferritin Test |
Hemoglobin test:
Procedure:A drop of the capillary blood will be obtained from the middle finger after a prick and will be placed unto the hemoglobin meter strip and the results will be available within 2 seconds.This test will be performed by the investigator as a screening test.
Frequency:Once
Duration :3 minutes/each Sample
Serum Ferritin Test:
Procedure:2ml blood will be withdrawn from the samples who are aneamic which is confirmed by Hb Test. A ruotine procedure will be followed to collect the blood by the hospital lab technician and report will be collected by the investigator after two hours.
Frequency:Once
Duration:3 to 5 minutes/sample. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1. Students who are apparently healthy, Studying in BSc Nursing, PBBSc Nursing, Diploma in nursing (GNM) |
|
| ExclusionCriteria |
| Details |
1.Students who are laready diagnosed with anemia and on treatment
2.suffering from chronic blood loss, Gastro Intestinal pathology, infections, and chronic inflammatory diseases, on Iron supplement,Undergone minor or major surgery in past 1 year
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between anemia and Body Mass Index |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| those who are anemic and willing to do they came go for Serum Ferritin level for further investigation |
1 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
25/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A descriptive research design will be used in the study. Thetarget population consists of undergraduate and diploma students studying in a nursing college at Mangaluru. The subjects will be selected through purposive sampling technique and calculated sample size for the screening phase is 300. Subjects who are diagnosed with anemia and on treatment taking iron tablets and within 3 months preceeding the data collection, Suffering from chronic blood loss, gastrointestinal pathology, infections and chronic inflammatory diseases, subjects who are on iron supplements and who had undergone minor or major surgery in past 1 year will be excluded from the study.Researcher develoved baseline proforma and WHO classification/cutoff values will be used for both anemia and BMI categorization. A digital hemoglobinometer, inchtape, weighing machine will be used for screening test. Iron deficiency anemia will be confirmed by serun Ferritin lab investigation for subjects with anemia |