A Phase 3 interventional study of Multiple Micronutrient Supplements with 30 mg of elemental iron and Multiple Micronutrient Supplements with 45 mg of elemental iron in Pregnancy Related, sponsored by George Washington University. Active, not recruiting at 1 site in Tanzania. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by George Washington University · Phase 3, Interventional, and Prevention
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.
George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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
Dietary Supplement: Multiple Micronutrient Supplements with 30 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 45 mg of elemental iron · Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron
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.
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.
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 for one month.
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
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
Diarrhea
The percentage of patients with self-reported diarrhea symptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Heartburn
The percentage of patients with self-reported heartburn symptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Constipation
The percentage of patients with self-reported constipation symptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Vomiting
The percentage of patients with self-reported vomiting during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Nausea
The percentage of patients with self-reported nausea symptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Leg cramps
The percentage of patients with self-reported leg cramp symptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Lower back/pelvic pain
The percentage of patients with self-reported lower back/pelvic painsymptoms during each intervention period
Time frame: At one month of taking each regimen, up to 3 months
Plan to share: Yes — deidentified analytical dataset supporting published research
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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George Washington University