Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
ConditionPregnancy Related
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorge Washington University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multiple Micronutrient Supplements with 30 mg of elemental iron
Dietary supplementMMS 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
Dietary supplementMMS 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
Dietary supplementMMS 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.
Treatment groups
6,381 Participants
are divided into 3 treatment groupsGroup A: MMS with 30 mg ironActive comparator 1 intervention
Group B: MMS with 45 mg ironExperimental treatment 1 intervention
Group C: MMS with 60 mg ironExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of pregnant women with third-trimester moderate or severe anemia
Defined as a hemoglobin concentration \<10 g/dL.
Time frame
3rd trimester (weeks 28-42 of pregnancy)Secondary outcomes
1
Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Time frame
3rd trimester (weeks 28-42 of pregnancy)2
Maternal hemoglobin concentration
Continuous hemoglobin concentration measured from venous blood by complete blood count
Time frame
6 weeks postpartum3
Proportion of pregnant women with anemia
Hb concentration \< 11 g/dL
Time frame
3rd trimester (weeks 28-42 of pregnancy)4
Proportion of postpartum women with anemia
Hb concentration \< 12 g/dL
Time frame
6 weeks postpartumOther outcomes
1
Percent adherence
The percentage of days a pregnant woman takes a MMS pill out of the total number of days from randomization to delivery
Time frame
During pregnancy (up to week 42)2
Diarrhea
Self-reported any diarrhea symptoms during the intervention period
Time frame
During pregnancy (up to week 42)3
Heartburn
Self-reported any heartburn symptoms during the intervention period
Time frame
During pregnancy (up to week 42)4
Constipation
Self-reported any constipation symptoms during the intervention period
Time frame
During pregnancy (up to week 42)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
George Washington University
Lead sponsor
Ifakara Health Institute
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator
Africa Academy for Public Health
Collaborator
Columbia University
Collaborator
Source ClinicalTrials.gov