Multiple Micronutrient Supplementation (MMS) Vs IFA Acceptability Crossover Trial (MIFA-ACT)

George Washington University (GW)

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: Pregnancy Related

Treatments: Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron; Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron

Study type: Interventional

Funder types: Other

Identifiers

NCT06069856

MIFA-ACT

Details and patient eligibility

About

This is an individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Attending first ANC visit at the study clinic
• Pregnant women ≤ 15 weeks of gestation
• Aged ≥ 18 years
• Intending to stay in the study area for the duration of study
• Provides informed consent

Exclusion criteria

• Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care)
• Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
• Concurrent participation in other nutritional supplementation trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups

MMS with 60 mg of iron first, then IFA with 60 mg of iron

Experimental group

Description:

Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months

Treatment:

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

Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron

IFA with 60 mg of iron first, then MMS with 60 mg of iron

Experimental group

Description:

Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months

Treatment:

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

Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron