Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

4,368

Participants

Timeline

Start Date

March 15, 2021

Primary Completion Date

December 14, 2023

Study Completion Date

January 21, 2024

Conditions
Iron Deficiency AnemiaInfant, Low Birth WeightAnemia of Pregnancy
Interventions
DRUG

Ferric carboxymaltose

Pregnant participants randomized to intervention arm 1 will receive a single dose of ferric carboxymaltose having 1000mg of iron if they weigh over 50kg. If a participant is under 50kg, they will receive a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This will be given ideally immediately after randomization, sometime between 14 weeks and 17 weeks of pregnancy.

DRUG

Iron isomaltoside

Pregnant participants randomized to intervention arm 1 will receive a single dose of iron isomaltoside having 1000mg of iron if they weigh over 50kg. If a participant is under 50kg, they will receive a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This will be given ideally immediately after randomization, sometime between 14 weeks and 17 weeks of pregnancy.

DRUG

Ferric Sulfate

Pregnant participants randomized to the oral iron arm will be given 200 ferrous sulphate tablets with 60mg elemental iron each, immediately after randomization, and instructed to take two per day (one in the morning and one at night) throughout the remainder of their pregnancy.

Trial Locations (4)

Unknown

S. Nijalingappa Medical College, Bagalkot

Jawaharlal Nehru Medical College, Belagavi

Raichur Institute of Medical Sciences, Rāichūr

Sawai Man Singh Medical College, Jaipur

All Listed Sponsors
collaborator

Children's Investment Fund Foundation

OTHER

collaborator

Jawaharlal Nehru Medical College

OTHER

collaborator

S. Nijalingappa Medical College

UNKNOWN

collaborator

Raichur Institute of Medical Sciences

UNKNOWN

collaborator

Sawai Mansingh Medical College

OTHER_GOV

lead

Thomas Jefferson University

OTHER

NCT05358509 - Reducing Anemia in Pregnancy in India: the RAPIDIRON Trial | Biotech Hunter | Biotech Hunter