Iron and Immune Response to Vaccine (IRONMUM)

NAEnrolling by invitationINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 18, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Pregnancy Related
Interventions
DIETARY_SUPPLEMENT

Sangobion and Thiamine Hydrochloride

"Prophylactic dietary supplements: 1 capsule of Sangobion + separate Thiamine Hydrochloride tablet 100mg per day for 12 weeks.~Then non-anaemic pregnant women will continue with prophylactic nutritional supplements until delivery."

DIETARY_SUPPLEMENT

Sangobion, Thiamine hydrochloride and Vitamin B12

"Treatment dietary supplements: 3 capsules of Sangobion + separate Thiamine Hydrochloride tablet 100mg, Vit B12 100mcg per day for 12 weeks.~If experience a therapeutic increase of 3% Haematocrit within 28 days (responders), they will continue with prophylactic nutritional supplements until delivery.~If no affect in Haematocrit level within 28 days (non-responders; defined by trimester of diagnosis), they will be investigated for their serum ferritin and if this is low (\<15ng/mL) intravenous (iv) iron supplement (Venofer®) will be provided. The dose will be calculated for the individual concerned (required iron dose (mg) = (2.4 x (target Hb of 11g/dL (Ht 33%) x pre-pregnancy weight (kg) +1000mg for replenishment of stores). Doses will be administered by slow iv infusion 200 mg per dose (maximum of 3 doses per week).~Following treatment they will continue with prophylactic nutritional supplements."

Trial Locations (1)

63110

Shoklo Malaria Research Unit (SMRU), Mae Sot

All Listed Sponsors
lead

University of Oxford

OTHER