Clinical trial NCT06079918: Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pregnancy Related
Keywords: Pregnancy
Multiple Micronutrient Supplementation
Iron
Anemia
Tanzania
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Ifakara Health Institute
name: Harvard School of Public Health (HSPH)
name: Muhimbili University of Health and Allied Sciences
name: Africa Academy for Public Health
name: Columbia University
First posted: 2023-10-12
Enrollment: 6381
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of pregnant women with third-trimester moderate or severe anemia
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
Secondary outcomes:
measure: Maternal hemoglobin concentration
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Maternal hemoglobin concentration
timeFrame: 6 weeks postpartum
measure: Proportion of pregnant women with anemia
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of postpartum women with anemia
timeFrame: 6 weeks postpartum
measure: Maternal serum ferritin
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of pregnant women with iron deficiency
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of pregnant women with iron deficiency anemia
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of women with preeclampsia
timeFrame: From 20 weeks gestation through delivery
measure: Proportion of women with antepartum bleeding
timeFrame: From 24 weeks gestation through delivery
measure: Proportion of women with postpartum hemorrhage
timeFrame: From delivery through 42 days post delivery
measure: Proportion of women with infection-related severe maternal outcomes
timeFrame: During pregnancy through 42 days postpartum
measure: Proportion of women with pregnancy-related death
timeFrame: Pregnancy through 42 days of pregnancy termination
measure: Proportion of women with symptoms consistent with depression
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of women with symptoms consistent with depression
timeFrame: 6 weeks postpartum
measure: Proportion of women with symptoms consistent with fatigue
timeFrame: 3rd trimester (weeks 28-42 of pregnancy)
measure: Proportion of women with symptoms consistent with fatigue
timeFrame: 6 weeks postpartum
measure: Proportion of women with malaria infection
timeFrame: Pregnancy through 42 days postpartum
measure: Proportion of fetal deaths
timeFrame: At pregnancy termination (weeks 1-42 of pregnancy)
measure: Proportion of stillbirths
timeFrame: At pregnancy termination (weeks 1-42 of pregnancy)
measure: Birthweight
timeFrame: At birth
measure: Proportion of live births with low birthweight
timeFrame: At birth
measure: Gestational age at birth
timeFrame: At birth
measure: Proportion of preterm live births
timeFrame: At birth
measure: Birthweight for gestational age
timeFrame: At birth
measure: Proportion of small-for-gestational age live births (<10th percentile)
timeFrame: At birth
measure: Proportion of small-for-gestational age live births (<3rd percentile)
timeFrame: At birth
measure: Infant hemoglobin concentration
timeFrame: At 6 weeks of age
measure: Infant serum ferritin
timeFrame: At 6 weeks of age
measure: Proportion of infants with iron deficiency
timeFrame: At 6 weeks of age
measure: Proportion of neonatal deaths
timeFrame: From birth to 28 days of age
measure: Proportion of infant deaths < 42 days
timeFrame: From birth to 42 days of age
Other outcomes:
measure: Percent adherence
timeFrame: During pregnancy (up to week 42)
measure: Diarrhea
timeFrame: During pregnancy (up to week 42)
measure: Heartburn
timeFrame: During pregnancy (up to week 42)
measure: Constipation
timeFrame: During pregnancy (up to week 42)
measure: Vomiting
timeFrame: During pregnancy (up to week 42)
measure: Nausea
timeFrame: During pregnancy (up to week 42)
measure: Leg Cramps
timeFrame: During pregnancy (up to week 42)
measure: Low back/pelvic pain
timeFrame: During pregnancy (up to week 42)
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Columbia University
name: Blair Wylie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Honorati Masanja, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Africa Academy for Public Health
name: Alfa Muhihi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Andrea Pembe, MD, MMed, PhD, FCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: The Goerge Washington University
name: Emily R Smith, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Christopher R Sudfeld, ScD, ScM
role: PRINCIPAL_INVESTIGATOR
References: