A study to compare the effectiveness of multiple micronutrient supplement Vs iron and folic-acid supplement for anemia prophylaxis among pregnant women.

Completed

• Conditions: Non-anemic pregnant women

• Registration Number: CTRI/2020/11/028999
• Lead Sponsor: Dr Anjusha Ranjith

Brief Summary

This study is a double blinded, parallel group, non-inferiority randomized controlled trial comparing the safety and efficacy of oral multiple micronutrient supplement 1 tablet daily and oral iron and folic-acid supplement 1 tablet daily for 180 days in 200 non-anemic pregnant women, that will be conducted in 6 subcentres under PHC Chhainsa and 6 subcentres under PHC Dayalpur in Haryana, India. The primary outcome measure will be change in hemoglobin level after 180 days of supplementation. The secondary outcomes will be change in serum ferritin levels , serum Vitamin B-12 levels and serum folate levels after 180 days of supplementation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-15
• Study Completion: 2021-09-09
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

(1) Pregnant women less than or equal to 12 weeks of gestation, (2) non-anemic with hemoglobin value between 11 g/dl and 14 g/dl, (3) those who are willing to stay at the current address during their entire pregnancy.

Exclusion Criteria

(1) If taking iron supplements for more than 1 month or received intravenous iron/ blood transfusion in the past 6 months, (2) diagnosed hypertension, overt diabetes, multiple pregnancy, (3) patient diagnosed with an illness which can alter the hemoglobin values including malabsorption, hemoglobinopathies, hemorrhage in the last 1 month etc., (4) diagnosed psychiatric illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin level	180 days

Secondary Outcome Measures

Name	Time	Method
Change in serum ferritin	180 days
Change in serum Vitamin B-12	180 days
Change in serum folate	180 days

Trial Locations

Locations (1)

Govt. Hospital (CRHSP Ballabgarh); 🇮🇳 Faridabad, HARYANA, India

Govt. Hospital (CRHSP Ballabgarh)

🇮🇳Faridabad, HARYANA, India

Dr Anjusha Ranjith

Principal investigator

9567616570

anjusha.ranjith01@gmail.com