Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania (MMS-MAP)

George Washington University (GW)

Status and phase: Enrolling; Phase 3

Conditions: Pregnancy Related

Treatments: Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron; Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron

Study type: Interventional

Funder types: Other

Identifiers

NCT06079918

MMS-MAP

Details and patient eligibility

About

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.

Enrollment: 6,381 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,381 participants in 3 patient groups

MMS with 30 mg iron

Active Comparator group

Description:

MMS with standard UNIMMAP formulation of 15 micronutrients, including 30 mg of iron

Treatment:

Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron

MMS with 45 mg iron

Experimental group

Description:

MMS with 45 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

Treatment:

Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron

MMS with 60 mg iron

Experimental group

Description:

MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients

Treatment:

Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron