| CTRI Number |
CTRI/2025/09/094155 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
LONGITUDINAL ANALYTICAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of nutritional anemia and its recovery after 8 weeks of therapy in children with severe acute malnutrition versus normal nutrition |
|
Scientific Title of Study
|
Comparative study of nutritional anemia and its recovery after 8 weeks of therapy in children with severe acute malnutrition versus normal nutrition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K AKSHYA |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
WARD 19A, DEPARTMENT OF PEDIATRICS, MAULANA AZAD MEDICAL COLLEGE, 2, BAHADURSHAH ZAFAR MARG, NEW DELHI -02
Central
DELHI
110002
India |
| Phone |
9818304305 |
| Fax |
|
| Email |
kakshya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAGHVENDRA SINGH |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS, MAULANA AZAD MEDICAL COLLEGE, 2, BAHADURSHAH ZAFAR MARG, NEW DELHI -02
Central
DELHI
110002
India |
| Phone |
9811898693 |
| Fax |
|
| Email |
drraghvendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAGHVENDRA SINGH |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PEDIATRICS, MAULANA AZAD MEDICAL COLLEGE, 2, BAHADURSHAH ZAFAR MARG, NEW DELHI -02
Central
DELHI
110002
India |
| Phone |
9811898693 |
| Fax |
|
| Email |
drraghvendrasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
2, BAHADURSHAH ZAFAR MARG, NEW DELHI-02 |
| Type of Sponsor |
Government medical college |
|
|
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 K AKSHYA |
Lok Nayak Hospital |
ROOM NO 517, PEDIATRICS OPD FIFTH FLOOR, OPD BUILDING MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL
New Delhi
DELHI |
9818304305
kakshya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (2) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NUTRITIONAL ANEMIA IN CHILDREN WITH NO MALNUTRITION |
Children, aged 6 to 59months with features suggestive of anemia with no malnutrition |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
GROUP 1 - CHILDREN, AGED 6 TO 59 MONTHS WITH ANEMIA AND SEVERE ACUTE MALNUTRITION (IN REHABILITATION PHASE) WITH NO COMPLICATIONS
GROUP 2 - CHILDREN, AGED 6 TO 59MONTHS WITH FEATURES SUGGESTIVE OF ANEMIA WITH NORMAL NUTRITION WILL BE SCREENED FOR ANEMIA AND IF FOUND ELIGIBLE WILL BE INCLUDED IN THE GROUP 2 |
|
| ExclusionCriteria |
| Details |
Children with: -
1.Secondary malnutrition.
2.Known diagnosis of Tuberculosis or are HIV positive.
3.Known diagnosis of any non-nutritional anemia (hemoglobinopathies).
4.Known diagnosis of Celiac disease or other malabsorptive states.
5.Known diagnosis of chronic kidney disease.
6.Past history of intake of hematinics or blood transfusion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare resolution of anemia after 8 weeks of treatment in children with severe acute malnutrition versus with normal nutrition aged 6 to 59 months |
DAY 56
WHERE DAY 0 IS THE DAY OF INITIATION OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To characterise the type of anemia and rate of hemoglobin recovery in the two groups |
Day 56 were day 0 is the day of initiation of treatment |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/09/2025 |
| 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
|
THE RESOLUTION OF ANEMIA IN CHILDREN WITH SEVERE ACUTE MALNUTRITION IS EXPECTED TO BE POORER COMPARED TO THE CHILDREN WITH NORMAL NUTRITIONAL STATUS. THIS COMPARATIVE OBSERVATIONAL STUDY, WHERE THE SUBJECTS WILL BE FOLLOWED UP OVER 8 WEEKS AND WILL RECEIVE APPROPRIATE TREATMENT AS PER STANDARD PROTOCOLS, AIMS TO EXPLORE AND COMPARE THE RECOVERY PATTERN OF NUTRITIONAL ANEMIA IN THESE TWO DISTINCT GROUPS - CHILDREN WITH SEVERE ACUTE MALNUTRITION AND THOSE WITH NORMAL NUTRITIONAL STATUS. |