| CTRI Number |
CTRI/2023/08/056597 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
15/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the benefit of alternate day versus daily oral iron therapy in iron deficient children |
|
Scientific Title of Study
|
Efficacy of alternate day versus daily oral iron therapy in children with iron deficiency anemia- A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRANATI GROVER |
| Designation |
MD Paediatrics |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College,Nehru Nagar, KLE Hospital road
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8106161797 |
| Fax |
|
| Email |
pranati.grover@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ABHILASHA SAMPAGAR |
| Designation |
PROFESSOR |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Paediatric Hematologist Oncologist,
Department of Medical Oncology
Jawaharlal Nehru Medical college, Nehru Nagar, KLE Hospital road
Belgaum
KARNATAKA
590010
India |
| Phone |
9686187023 |
| Fax |
|
| Email |
abhilasha.pedia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRANATI GROVER |
| Designation |
MD PAEDIATRICS |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics
Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA
590010
India |
| Phone |
8106161797 |
| Fax |
|
| Email |
pranati.grover@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belagavi |
|
|
Primary Sponsor
|
| Name |
DR PRANATI GROVER |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College KLE University Belagavi |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 PRANATI GROVER |
KLEs Dr. PRABHAKAR KORE HOSPITAL BELAGAVI |
Department of Paediatrics , Jawaharlal Nehru Medical College, Nehru Nagar, KLE Hospital Road
Belgaum
KARNATAKA |
8106161797
pranati.grover@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
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 |
| Comparator Agent |
Effect of alternate day versus daily oral iron therapy |
Alternate day versus twice daily oral iron therapy |
| Intervention |
Oral Ferrous fumarate preparation |
Oral ferrous fumarate preparation to be given on alternate days versus twice daily.
Dose for both the groups is 4mg/kg.
Route of administration is oral.
After 1 month of supplements cbc will be repeated again to know the effect and after that we should continue the supplements for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 6 months to 10 years of age diagnosed with iron deficiency anemia |
|
| ExclusionCriteria |
| Details |
Patients who have received blood transfusion in past 3 months, oral or injectable iron supplements, patients with hemoglobinopathies, premature infants born before 32 weeks of gestation, patient with active infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of alternate versus twice daily oral iron therapy in children with iron deficiency anemia |
Over a span of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Effect of alternate versus twice daily oral iron therapy on serum hepcidin levels
2. To compare the GI side effects in both the groups that may affect the compliance. |
Over a span of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/08/2023 |
| 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 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
|
Iron deficiency anemia is the leading cause of nutritional anemia in India. It can cause both hematological as well as non hematological consequences such as stunted growth and impaired cognitive functions.Large amount of unabsorbed iron can cause gastric inflammation and decrease the compliance. Alternate day Iron therapy is more efficient than daily Iron therapy in improving the hemoglobin levels and this can be attributed to the increased hepcidin levels after daily Iron dose. Hepcidin is a negative regulator of iron absorption and increased levels will lead to decrease iron absorption. |