Health TrialsbyHealthPanel

Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

ConditionPregnancy Related
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorge Washington University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Iron Folic Acid Tablets with 60 mg of iron

    Dietary 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 iron

    Dietary 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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: MMS with 60 mg of iron first, then IFA with 60 mg of ironExperimental treatment 2 interventions
Group B: IFA with 60 mg of iron first, then MMS with 60 mg of ironExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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
3

Adherence

Percentage pill count of the number of supplements taken

Time frame
At two months of taking each regimen

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Washington University

Lead sponsor

Ifakara Health Institute

Collaborator

Harvard School of Public Health (HSPH)

Collaborator

Muhimbili University of Health and Allied Sciences

Collaborator

Africa Academy for Public Health

Collaborator

Columbia University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: