Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

Phase 3Active Not RecruitingNCT06069869

George Washington University156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

156

Conditions

Pregnancy Related

Interventions

Multiple Micronutrient Supplements with 30 mg of elemental ironDIETARY_SUPPLEMENT

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 for one month.

Multiple Micronutrient Supplements with 45 mg of elemental ironDIETARY_SUPPLEMENT

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 for one month.

Multiple Micronutrient Supplements with 60 mg of elemental ironDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,SC, CC genotype) as tested by HemoTypeSC * Concurrent participation in other nutritional supplementation trial * Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Locations (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Outcomes

Primary Outcomes

Acceptability of MMS formulations

Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

Time frame: At one month of taking each regimen, up to 3 months

Secondary Outcomes

Most preferred MMS formulation

Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the best.

Time frame: At three months (after taking all three regimens)

Least preferred MMS formulation

Participant's reported preference for MMS formulations with 30 mg, 45 mg, or 60 mg of iron by asking which supplement participant likes the least.

Time frame: At three months (after taking all three regimens)

Identification of MMS iron dosage

Percentage of participants that correctly identify their iron dose treatment order

Time frame: At three months (after taking all three regimens)

Side effects of MMS formulations

The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period

Time frame: At one month of taking each regimen, up to 3 months

Adherence

The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period

Time frame: At one month of taking each regimen, up to 3 months

Data from ClinicalTrials.gov

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