drugset / Trial / NCT04012177

Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

NCT04012177

RandomizedParallel-groupSingle-blindTreatment

Summary

This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon after birth (approximately within 72 hours). This is an open label, community-based, randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome assessor will be blinded. The comparison groups are control arm (only routine ANC care and nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus Choline and Nicotinamide arm.

Timeline

Start
2019-07-22
Primary completion
2022-09-05
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 2000 mg Oral
Subject Choline Bitartrate Small molecule 450 mg Oral
Subject Nicotinamide Other / unclassified 100 mg Oral