| CTRI Number |
CTRI/2023/08/056557 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Oral Vitamin C in addition to Iron Folic Acid tablet for treatment of Anemia in Adolescent girls. |
|
Scientific Title of Study
|
Role of Oral Vitamin C in addition to Iron Folic Acid supplementation for treatment of Anemia in School going Adolescent girls: An Interventional study from Central India. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohini Desai |
| Designation |
Postgraduate student |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Dept. of Community Medicine, Government Medical College Nagpur, Hanuman Nagar, Ajni road, Medical Chowk
Nagpur
MAHARASHTRA
440003
India |
| Phone |
|
| Fax |
|
| Email |
rohinidesai92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujwala Ukey |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Department of Community Medicine, Govt. Medical College, Nagpur, Hanuman Nagar, Ajni Road, Medical Chowk.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
|
| Fax |
|
| Email |
drujwalachitre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohini Desai |
| Designation |
Community Medicine Postgraduate student |
| Affiliation |
Government Medical College, Nagpur |
| Address |
Dept of Community Medicine, Government Medical College Nagpur, Hanuman Nagar, Ajni Road, Medical Chowk.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
|
| Fax |
|
| Email |
rohinidesai92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine, Government Medical College Nagpur, Hanuman nagar, Ajni road, Medical chowk, Nagpur, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Rohini |
Government Medical College and Hospital Nagpur |
GMC Nagpur, Dept.of Community Medicine, Hanuman Nagar, Ajni road, Medical Chowk, Ajni.
Nagpur
MAHARASHTRA |
9892598560
rohinidesai92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMC Nagpur |
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 |
IFA tablets |
2 IFA tablets (60 mg elemental Fe
+ 500 mcg folic acid) BD for a period of 12 weeks |
| Intervention |
Iron Folic Acid tablets and
Tablet Vitamin C |
2 tablets of Iron folic acid supplement (60
mg elemental iron + 500 mcg
Folic Acid) BD and one tablet of Vitamin C (500 mg) OD for a period of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls in the age group of 10-19 years with mild to moderate anemia (8-11.9 gm%) |
|
| ExclusionCriteria |
| Details |
1)Adolescent girls not willing to give consent for the study.
2)Known cases of Sickle cell Anemia, thalassemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The haemoglobin level measured by any of the standard recommended method will be the primary outcome |
3 months. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2023 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Approval has been obtained from GMC Nagpur Ethics Committee. This Interventional study will be conducted at School located near to Institute (Hanuman Nagar). Adolescent girls in the age group of 10-19 years diagnosed with mild to moderate anemia will be approached. Eligible subjects will be recruited after obtaining informed consent from them. Baseline Hemoglobin of subjects will be done. Random selection of subjects will be done and then Probability proportionate to size sampling will be done.
Deworming of subjects with Tablet Albendazole will be done. Intervention group participants will be given Tab Iron folic acid (60mg elemental iron + 500mcg Folic Acid) 2 tablets, along with Tab Vitamin C supplementation (500mg) OD one tablet. Control group will be given Tab Iron folic acid (60mg elemental iron + 500mcg Folic Acid) 2 tablets. Intervention will be for 3 months.
Adherence will be assessed in 2 ways; by collecting empty blister pack and by using MARS scale.
|