| CTRI Number |
CTRI/2025/03/083346 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Long term iron balance in Women of Reproductive Age with Human Immunodeficiency Virus Infection |
|
Scientific Title of Study
|
The impact of chronic inflammation on long term iron absorption in women of reproductive age with Human Immunodeficiency Virus Infection using iron isotope dilution method A cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savitha Anne Sebastian |
| Designation |
Associate Professor |
| Affiliation |
St Johns Medical College, Bengaluru |
| Address |
Department of Medicine
St Johns Medical College Hospital,
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9663780301 |
| Fax |
|
| Email |
savitha.as@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Savitha Anne Sebastian |
| Designation |
Associate Professor |
| Affiliation |
St Johns Medical College, Bengaluru |
| Address |
Department of Medicine
St Johns Medical College Hospital,
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9663780301 |
| Fax |
|
| Email |
savitha.as@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Savitha Anne Sebastian |
| Designation |
Associate Professor |
| Affiliation |
St Johns Medical College, Bengaluru |
| Address |
Department of Medicine
St Johns Medical College Hospital,
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Sarjapur Road, John Nagar, Koramangala, Bengaluru - 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9663780301 |
| Fax |
|
| Email |
savitha.as@stjohns.in |
|
|
Source of Monetary or Material Support
|
| International Atomic Energy Agency. Vienna International Centre, P.O. Box 100, A-1400 Vienna, Austria |
| St Johns Medical College Hospital, Sarjapur Road, Bangalore, Karnataka, India 560034. |
|
|
Primary Sponsor
|
| Name |
International Atomic Energy Agency |
| Address |
Vienna International Centre, P.O. Box 100, A-1400 Vienna, Austria |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Savitha Anne Sebastian |
St Johns Medical College Hospital |
Medicine OPD (Room No 5) at SJMCH, Sarjapur Road, Koramangala, Bengaluru - 560034
Bangalore
KARNATAKA |
9663780301
savitha.as@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St Johns Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
WRA with HIV infection
Known HIV positive status and stable on ART who are:
Non pregnant (negative on urine pregnancy test), non-lactating WRA, Hb more than 11g/dL, Corrected serum ferritin more than 50mcg/L, CRP more than 5mg/L |
|
| ExclusionCriteria |
| Details |
Healthy control WRA
History of
-Major illnesses or blood transfusion in the last three months prior to study
-Current anticoagulation use, for any indication
-Menorrhagia for preceding 3 months
-Other chronic inflammatory states/ diseases - Diabetes Mellitus, Rheumatoid arthritis, chronic obstructive pulmonary disease, severe obesity, Inflammatory bowel disease, ischemic heart disease, malignancy and Chronic liver disease.
WRA with HIV infection
-Same as those for healthy control WRA and
-Opportunistic infections (OI) requiring hospitalisation or treatment of more than a week in the last three months prior to study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative estimate of the difference in long term iron balance due to effect of HIV induced chronic inflammation in WRA with HIV infection as compared to healthy controls. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Labelled cohort that allows for subsequent testing of iron supplement interventions or absorption enhancers |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/06/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Study objective: To compare the effect of chronic inflammation on long-term iron absorption, between WRA with and without HIV infection using the stable iron isotope dilution technique over 6 months.
Study Design: 2 arm prospective cohort study
Outcomes: 1. Quantitative estimate of the difference in long term iron balance due to effect of HIV induced chronic inflammation in WRA with HIV infection as compared to healthy controls. 2. Labelled cohort that allows for subsequent testing of iron supplement interventions or absorption enhancers
Sample size: n=40, 20 in each arm
Recruitment: 1 year; Follow-up: for 1.5 years
|