Effect of Oral Vitamin C in addition to Iron Folic Acid tablet for treatment of Anemia in Adolescent girls.

Phase 4

Recruiting

• Conditions: Iron deficiency anemia, unspecified,

• Registration Number: CTRI/2023/08/056557
• Lead Sponsor: No sponsor

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-20
• Last Update Posted: 2024-06-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

Adolescent girls in the age group of 10-19 years with mild to moderate anemia (8-11.9 gm%).

Exclusion Criteria

• 1)Adolescent girls not willing to give consent for the study.
• 2)Known cases of Sickle cell Anemia, thalassemia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The haemoglobin level measured by any of the standard recommended method will be the primary outcome	3 months.

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (1)

Government Medical College and Hospital Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Medical College and Hospital Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Rohini

Principal investigator

9892598560

rohinidesai92@gmail.com