Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

Phase 3Not Yet RecruitingNCT06069856

George Washington University130 enrolled

Overview

This is an open-label 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

130

Conditions

Pregnancy Related

Interventions

Iron Folic Acid Tablets with 60 mg of ironDIETARY_SUPPLEMENT

IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization

Multiple Micronutrient Supplements with 60 mg of elemental ironDIETARY_SUPPLEMENT

MMS 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.

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 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,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.

Outcomes

Primary Outcomes

Acceptability of formulation

To assess acceptability of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot).

Time frame: At two months of taking each regimen

Secondary Outcomes

Most preferred formulation

To assess participated reported preference of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron by asking participants which supplement they like the best.

Time frame: At four months (after taking both regimens)

Side Effects of formulation

To assess the percentage of patients experiencing side effects of MMS formulation with 60 mg of iron and IFA formulation with 60 mg of iron

Time frame: At two months of taking each regimen

Adherence

Percentage pill count of the number of supplements taken

Time frame: At two months of taking each regimen

Central Contacts

Emily R Smith, ScD, MPH

CONTACT

202-994-3589 emilysmith@gwu.edu

Christopher R Sudfeld, ScD, ScM

CONTACT

csudfeld@hsph.harvard.edu

Data from ClinicalTrials.gov

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