Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

Pregnancy Related Clinical Trial

— MMS-MAP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079918
• Other study ID #: MMS-MAP
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: George Washington University
• Contact: Emily R Smith, ScD, MPH
• Phone: +1 2029943589
• Email: emilysmith[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6381
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Attending first ANC visit at study clinics

• Pregnant women < 20 weeks gestation (up to 19 weeks and 6 days) 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

Related Conditions & MeSH terms

• Anemia
• Pregnancy Related

Intervention

Dietary Supplement:
• Multiple Micronutrient Supplements with 30 mg of elemental iron
MMS with 30 mg iron is the active comparator group. The standard UNIMMAP MMS formulation includes 30 mg of iron which will be taken orally once daily from the time of randomization until delivery.
• Multiple Micronutrient Supplements with 45 mg of elemental iron
MMS with 45 mg iron is an intervention group. MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.
• Multiple Micronutrient Supplements with 60 mg of elemental iron
MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization until delivery.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
George Washington University	Africa Academy for Public Health, Columbia University, Harvard School of Public Health (HSPH), Ifakara Health Institute, Muhimbili University of Health and Allied Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent adherence	The percentage of days a pregnant woman takes a MMS pill out of the total number of days from randomization to delivery	During pregnancy (up to week 50)
Other	Diarrhea	Self-reported any diarrhea symptoms during the intervention period	During pregnancy (up to week 50)
Other	Heartburn	Self-reported any heartburn symptoms during the intervention period	During pregnancy (up to week 50)
Other	Constipation	Self-reported any constipation symptoms during the intervention period	During pregnancy (up to week 50)
Other	Vomiting	Self-reported any vomiting symptoms during the intervention period	During pregnancy (up to week 50)
Other	Nausea	Self-reported any nausea symptoms during the intervention period	During pregnancy (up to week 50)
Other	Leg Cramps	Self-reported any leg cramps during the intervention period	During pregnancy (up to week 50)
Other	Low back/pelvic pain	Self-reported any low back/pelvic pain during the intervention period	During pregnancy (up to week 50)
Primary	Proportion of pregnant women with third-trimester moderate or severe anemia	Defined as a hemoglobin concentration <10 g/dL.	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Maternal hemoglobin concentration	Continuous hemoglobin concentration measured from venous blood by complete blood count	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Maternal hemoglobin concentration	Continuous hemoglobin concentration measured from venous blood by complete blood count	6 weeks postpartum
Secondary	Proportion of pregnant women with anemia	Hb concentration < 11 g/dL	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of postpartum women with anemia	Hb concentration < 12 g/dL	6 weeks postpartum
Secondary	Maternal serum ferritin	Inflammation-adjusted serum ferritin	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of pregnant women with iron deficiency	Inflammation-adjusted serum ferritin < 15 ug/L	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of pregnant women with iron deficiency anemia	Anemia (Hb < 10 g/dL) and iron deficiency (inflammation-adjusted serum ferritin < 15 ug/L)	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of women with preeclampsia	Gestational hypertension and gestational proteinuria among participants without chronic hypertension or gestational proteinuria among participants with chronic hypertension (superimposed preeclampsia) or clinical diagnosis of preeclampsia by managing clinical team or development of severe features of preeclampsia even in the absence of proteinuria	From 20 weeks gestation through delivery
Secondary	Proportion of women with antepartum bleeding	Self-reported or clinical diagnosis of bleeding from or into the genital tract	From 24 weeks gestation through delivery
Secondary	Proportion of women with postpartum hemorrhage	Clinical diagnosis of postpartum hemorrhage or use of critical interventions to treat postpartum hemorrhage	From 24 weeks gestation through 42 days post delivery
Secondary	Proportion of women with peripartum infection	Severe infection-related such as hospitalization for infection, women presenting with WHO near-miss criteria to define organ system dysfunction, invasive procedure to treat the source of infection (vacuum aspiration, dilatation and curettage, wound debridement, drainage, laparotomy and lavage, other surgery), or maternal death and all other incident infections in the peripartum period.	During pregnancy through 42 days postpartum
Secondary	Proportion of women with pregnancy-related death	Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death	42 days within termination of pregnancy
Secondary	Proportion of women with symptoms consistent with depression	Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of women with symptoms consistent with depression	Patient Health Questionnaire-9 (PHQ-9) score ranging from 0 to 27, with higher number is consistent with depression and anxiety	6 weeks postpartum
Secondary	Proportion of women with symptoms consistent with fatigue	FACIT assessment score ranging from 0 to 52, with lower number is consistent with having fatigue.	3rd trimester (weeks 27-42 of pregnancy)
Secondary	Proportion of women with symptoms consistent with fatigue	FACIT assessment score ranging from 0 to 52, with lower number is consistent with having fatigue.	6 weeks postpartum
Secondary	Proportion of women with malaria infection	Based on HRP2 biomarker and rapid-diagnostic tests (RDTs)	Pregnancy through 42 days postpartum
Secondary	Proportion of fetal deaths	A product of human conception, irrespective of the duration of the pregnancy, which, after expulsion or extraction, does not breath or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached	At pregnancy termination (weeks 1-40 of pregnancy)
Secondary	Proportion of stillbirths	Fetal death = 28 weeks gestation	At pregnancy termination (weeks 1-40 of pregnancy)
Secondary	Birthweight	Continuous birthweight among live births	At birth
Secondary	Proportion of live births with low birthweight	Live birth with birthweight < 2500 g	At birth
Secondary	Gestational age at birth	Duration of gestation in weeks as a continuous measure among live births based on best obstetric estimate among live births	At birth
Secondary	Proportion of preterm live births	Live birth <37 weeks gestation (based on best obstetric estimate)	At birth
Secondary	Birthweight for gestational age	Continuous centile based on INTERGROWTH-21st standard birth centile among live births	At birth
Secondary	Proportion of small-for-gestational age live births (<10th percentile)	Size-for-gestational age <10th on the INTERGROWTH-21st standard among live births	At birth
Secondary	Proportion of small-for-gestational age live births (<3rd percentile)	Size-for-gestational age <3rd percentile on the INTERGROWTH-21st standard among live births	At birth
Secondary	Infant hemoglobin concentration	Continuous Hb concentration measured from capillary blood by complete blood count	At 6 weeks of age
Secondary	Infant serum ferritin	Continuous inflammation adjusted serum ferritin	At 6 weeks of age
Secondary	Proportion of infants with iron deficiency	Inflammation-adjusted serum ferritin < 20 ug/L	At 6 weeks of age
Secondary	Proportion of neonatal deaths	Death of liveborn infant during the first 28 completed days of life	From birth to 28 days of age
Secondary	Proportion of infant deaths < 42 days	Death of a live born infant during the first 42 completed days of life	From birth to 42 days of age