Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- George Washington University
- Enrollment
- 6,381
- Locations
- 1
- Primary Endpoint
- Proportion of pregnant women with third-trimester moderate or severe anemia
Study Overview
Brief Summary
This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Attending first ANC visit at study clinics
- •Pregnant women < 20 weeks gestation by last menstrual period (LMP)
- •Aged ≥ 18 years old
- •Intending to stay in Dar es Salaam until 6 weeks post delivery
- •Provides informed consent
Exclusion Criteria
- •Severe anemia (defined as hemoglobin < 8.5 g/dL per Tanzania standard of care)
- •Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
- •Concurrently enrolled in another nutritional clinical trial
- •Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
Arms & Interventions
MMS with 30 mg iron
MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron
Intervention: Multiple Micronutrient Supplements with 30 mg of elemental iron (Dietary Supplement)
MMS with 45 mg iron
MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Intervention: Multiple Micronutrient Supplements with 45 mg of elemental iron (Dietary Supplement)
MMS with 60 mg iron
MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients
Intervention: Multiple Micronutrient Supplements with 60 mg of elemental iron (Dietary Supplement)
Outcomes
Primary Outcomes
Proportion of pregnant women with third-trimester moderate or severe anemia
Time Frame: 3rd trimester (weeks 28-42 of pregnancy)
Defined as a hemoglobin concentration \<10 g/dL.
Secondary Outcomes
- Maternal hemoglobin concentration(6 weeks postpartum)
- Proportion of pregnant women with anemia(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of postpartum women with anemia(6 weeks postpartum)
- Maternal serum ferritin(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of pregnant women with iron deficiency(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of pregnant women with iron deficiency anemia(3rd trimester (weeks 28-42 of pregnancy))
- Proportion of women with preeclampsia(From 20 weeks gestation through delivery)
- Proportion of women with antepartum bleeding(From 24 weeks gestation through delivery)
- Proportion of women with postpartum hemorrhage(From delivery through 42 days post delivery)
- Proportion of women with infection-related severe maternal outcomes(During pregnancy through 42 days postpartum)
- Proportion of women with pregnancy-related death(Pregnancy through 42 days of pregnancy termination)
- Proportion of women with symptoms consistent with depression(6 weeks postpartum)
- Proportion of women with symptoms consistent with fatigue(6 weeks postpartum)
- Proportion of women with malaria infection(Pregnancy through 42 days postpartum)
- Proportion of fetal deaths(At pregnancy termination (weeks 1-42 of pregnancy))
- Proportion of stillbirths(At pregnancy termination (weeks 1-42 of pregnancy))
- Birthweight(At birth)
- Proportion of live births with low birthweight(At birth)
- Gestational age at birth(At birth)
- Proportion of preterm live births(At birth)
- Birthweight for gestational age(At birth)
- Proportion of small-for-gestational age live births (<10th percentile)(At birth)
- Proportion of small-for-gestational age live births (<3rd percentile)(At birth)
- Infant hemoglobin concentration(At 6 weeks of age)
- Infant serum ferritin(At 6 weeks of age)
- Proportion of infants with iron deficiency(At 6 weeks of age)
- Proportion of neonatal deaths(From birth to 28 days of age)
- Proportion of infant deaths < 42 days(From birth to 42 days of age)
Investigators
Emily Smith
Principal Investigator
George Washington University