| CTRI Number |
CTRI/2025/10/095863 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of iron on hemoglobin bands |
|
Scientific Title of Study
|
Relationship between iron profile and hemoglobin bands using UV-Visible spectrometer in individuals with anemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameeksha Chandrashekar Poojary |
| Designation |
Student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Medical Laboratory Technology, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353124826 |
| Fax |
|
| Email |
sameeksha1.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saritha Kamath U |
| Designation |
Professor |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Medical Laboratory Technology, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844344459 |
| Fax |
|
| Email |
Saritha.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sameeksha Chandrashekar Poojary |
| Designation |
Student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Department Of Medical Laboratory Technology, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9353124826 |
| Fax |
|
| Email |
sameeksha1.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Udupi District, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College Of Health Professions |
| Address |
Manipal Academy Of Higher Education, Manipal, Udupi District, Karnataka, India, 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Shobha U Kamath |
Kasturba Medical Hospital And Kasturba Medical College, Manipal |
Department of Biochemistry, Kasturba Medical Hospital And Kasturba Medical College, MAHE, Manipal, 576104
Udupi
KARNATAKA |
9845865848
Shobha.kamath@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Group 1:
Diagnosed with anemia (hemoglobin concentration from 6 g/dL to 10 g/dL)
Age : 20–30 years
All genders are included.
Participants with request for Complete Blood Count and Iron Profile
Group 2:
Individuals without anemia (hemoglobin concentration from 12g/dL to 15g/dL)
Age : 20–30 years
All genders are included.
Participants with request for Complete Blood Count and Iron Profile |
|
| ExclusionCriteria |
| Details |
Anemia caused by acute blood loss (e.g: Trauma, Surgery)
History of blood transfusion in the past 3 months.
Participants currently on medications /supplementation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hemoglobin banding pattern in OD
Iron-mg/dL
Ferritin-ng/mL
Correlate hemoglobin banding pattern with iron profile
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
16/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Anemia, a widespread health problem particularly in developing countries, is characterized by reduced hemoglobin and red blood cell levels. Hemoglobin, the primary oxygen transporter in red blood cells, is a tetramer composed of two alpha and two beta chains. Each chain contains a heme group with a central iron atom that binds oxygen, making iron indispensable for oxygen delivery. Structural variations in hemoglobin usually arise from point mutations leading to single amino acid substitutions in globin chains. While many variants have minimal clinical effect, some are more common and carry significant clinical consequences. Against this background, the present prospective cross-sectional study aims to assess the relationship between iron levels and hemoglobin banding patterns using UV–Visible spectrometer in 24 individuals aged 20–30 years, including 12 anemic cases and 12 controls. Participants will be voluntarily recruited from individuals visiting Kasturba Hospital for routine health checkups, based on specified inclusion and exclusion criteria and after obtaining informed consent. Data will be statistically analyzed using Jamovi software, applying descriptive statistics (mean, median, standard deviation) and Pearson correlation. This study may help identify additional hemoglobin bands in anemic patients, offering insights into structural variations of hemoglobin associated with anemia and clarifying how differences in iron status affect its structure and function. |