| CTRI Number |
CTRI/2024/05/066892 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the oral Iron folic acid syrup and Multiple micronutrient powder given daily , to prevent anemia in young age children,in rural population of Haryana . |
|
Scientific Title of Study
|
An open-labelled randomized controlled trial to compare the efficacy of oral Multiple micronutrient powder vs oral Iron and Folic Acid syrup IFAS given daily, for anemia prophylaxis among nonanemic children aged 6-24 months, in a rural population of Haryana, India
|
| 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 Kapil Yadav |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 37 , Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi- 110029
Room no-12 , Old OT block , Department of Centre for Community Medicine ,AIIMS New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9818420553 |
| Fax |
|
| Email |
dr.kapilyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Yadav |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 37 , Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi- 110029
Room no 12 , Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi- 110029
New Delhi
DELHI
110029
India |
| Phone |
9818420553 |
| Fax |
|
| Email |
dr.kapilyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritu Arya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no-14, Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi- 110029
Room no-12, Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi- 110029
New Delhi
DELHI
110029
India |
| Phone |
9818932652 |
| Fax |
|
| Email |
rituarya137@gmail.com |
|
|
Source of Monetary or Material Support
|
| CRHSP Ballabhgarh, Radha Nagar ,Faridabad district Haryana-121004 |
|
|
Primary Sponsor
|
| Name |
Dr Kapil Yadav |
| Address |
Room no 37 Old OT block, Department of centre for Community Medicine , AIIMS New Delhi-110029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ritu Arya |
Old OT block , Department of Centre for Community Medicine , AIIMS New Delhi-110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kapil Yadav |
CRHSP Ballabgarh |
CRHSP Ballabgarh ,Department of Centre for community Medicine ,Administration block, Faridabad district , Haryana -121004
Faridabad
HARYANA |
9818420553
dr.kapilyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee of the All India Institute Of Medical Science , New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Anemic Children aged 6-24 months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron folic acid syrup (IFAS) |
IFA syrup given daily, orally OD(1mg/kg/day dose , 1ml containing 20 mg of elemental iron and 100ug of folic acid )for period of 3 months . |
| Intervention |
Multiple micronutrient powder (MMP) |
MMP is given orally and daily OD(1 sachet per day containing 10 mg of elemental iron) for 3 months of period. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
21.00 Month(s) |
| Gender |
Both |
| Details |
Children between 6-21 months of age |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Hb level in gm/dl |
done at starting of trial and after 3 months of completion of trial . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Serum ferritin in ng/dl
2. Adherence to supplement |
After 3 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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="0"
Months="8"
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
|
This is a parallel group open labelled randomized control trial . This trial will be conducted in the intensive field practice area (IFPA), Ballabgarh , Haryana . Study population will be non- anemic children of age 6-24 months , who have been residents of the study area for at least past 6 months . In intervention arm , children will receive MMP ( 1 sachet / day ) daily for 3 months duration . In control arm children will receive oral iron and folic acid (IFA) syrup ( 1 mg/kg/day) for 3 months duration (1 ml IFA syyrup contains 20 mg elemental iron and 100mcg folic acid ). After 3 months of intervention , at the endline, we are planning to assess blood hemoglobin level ingm/dl as the primary outcome , and serum ferritin level in ng/dl and adherence to supplements as the secondary outcomes. |