Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial (MID-ACT)

George Washington University (GW)

Status and phase: Not yet 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

NCT06069869

MID-ACT

Details and patient eligibility

About

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.

Enrollment: 156 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 Dar es Salaam 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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156 participants in 6 patient groups

MM 30mg; then MMS 45mg; then MMS 60mg

Experimental group

Description:

Participants first receive MMS with 30 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 60 mg of iron for one month

Treatment:

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

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

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

MM 30mg; then MMS 60mg; then MMS 45mg

Experimental group

Description:

Participants first receive MMS with 30mg for one month, then MMS with 60mg of iron for one month, then MMS with 45 mg of iron for one month

Treatment:

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

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

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

MM 45mg; then MMS 30mg; then MMS 60mg

Experimental group

Description:

Participants first receive MMS with 45 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 60 mg of iron for one month

Treatment:

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

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

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

MM 45 mg; then MMS 60mg; then MMS 30mg

Experimental group

Description:

Participants first receive MMS with 45 mg for one month, then MMS with 60 mg of iron for one month, then MMS with 30 mg of iron for one month

Treatment:

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

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

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

MM 60mg; then MMS 30mg; then MMS 45mg

Experimental group

Description:

Participants first receive MMS with 60 mg for one month, then MMS with 30 mg of iron for one month, then MMS with 45 mg of iron for one month

Treatment:

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

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

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

MM 60mg; then MMS 45mg; then MMS 30mg

Experimental group

Description:

Participants first receive MMS with 60 mg for one month, then MMS with 45 mg of iron for one month, then MMS with 30 mg of iron for one month

Treatment:

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

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

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