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| Name | Class |
|---|---|
| Ifakara Health Institute | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Muhimbili University of Health and Allied Sciences | OTHER |
| Africa Academy for Public Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MM 30mg; then MMS 45mg; then MMS 60mg | Experimental | 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 |
|
| MM 30mg; then MMS 60mg; then MMS 45mg | Experimental | 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 |
|
| MM 45mg; then MMS 30mg; then MMS 60mg | Experimental | 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 |
|
| MM 45 mg; then MMS 60mg; then MMS 30mg | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Micronutrient Supplements with 30 mg of elemental iron | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At one month of taking each regimen, up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At three months (after taking all three regimens) |
| Least preferred MMS formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Diarrhea | The percentage of patients with self-reported diarrhea symptoms during each intervention period | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blair Wylie, MD, MPH | Columbia University | Principal Investigator |
| Honorati Masanja, PhD | Ifakara Health Institute | Principal Investigator |
| Alfa Muhihi, PhD | Africa Academy for Public Health | Principal Investigator |
| Andreas Pembe, MD, MMed, PhD, FCOG | Muhimbili University of Health and Allied Sciences | Principal Investigator |
| Emily R Smith, ScD, MPH | The George Washington University | Principal Investigator |
| Christopher R Sudfeld, ScD, ScM | Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42203269 | Derived | Sudfeld CR, Muhihi A, Sylvetsky AC, Metta E, Brownlee VS, Oakley EM, Bakari M, Fawzi WW, Kinyogoli S, Kuiper JR, Mugusi S, Pan Q, Sando MM, Wylie BJ, Masanja H, Smith ER, Pembe AB. Effect of iron dose in maternal multiple micronutrient supplement on perceived side effects, adherence, acceptability and preferences: protocol for a randomised crossover trial. BMJ Open. 2026 May 27;16(5):e118725. doi: 10.1136/bmjopen-2026-118725. |
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deidentified analytical dataset supporting published research
The deidentified analytical dataset supporting published research may be made available anytime after the date of publication and will be avialable indefinitely.
The deidentified analytical dataset supporting published research may be made available following a reasonable request submitted to the study team and completion of relevant ethical approvals and data transfer agreements
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| OTHER |
| Columbia University | OTHER |
Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).
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The trial is quadruple blind with all trial participants, outcome assessors (research staff and care providers), investigators, and trials statistician and data analysts being unable to determine the allocated trial arm for any trial participant or identify trial participants who are on the same trial regimen.
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| MM 60mg; then MMS 30mg; then MMS 45mg | Experimental | 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 |
|
| MM 60mg; then MMS 45mg; then MMS 30mg | Experimental | 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 |
|
| Multiple Micronutrient Supplements with 45 mg of elemental iron | Dietary 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 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 for one month. |
|
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. |
| At three months (after taking all three regimens) |
| Identification of MMS iron dosage | Percentage of participants that correctly identify their iron dose treatment order | 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 | 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 | At one month of taking each regimen, up to 3 months |
| 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 | At one month of taking each regimen, up to 3 months |
| Vomiting | The percentage of patients with self-reported vomiting during each intervention period | 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 | 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 | 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 | At one month of taking each regimen, up to 3 months |