Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMS with 60 mg of iron first, then IFA with 60 mg of iron | Experimental | Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months |
|
| IFA with 60 mg of iron first, then MMS with 60 mg of iron | Experimental | Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At two months of taking each regimen |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At four months (after taking both regimens) |
| Side Effects of formulation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily R Smith, ScD, MPH | Contact | 202-994-3589 | emilysmith@gwu.edu | |
| Christopher R Sudfeld, ScD, ScM | Contact | csudfeld@hsph.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Blair Wylie, MD, MPH | Columbia University | Principal Investigator |
| Honorati Masanja, PhD | Ifakara Health Institute | Principal Investigator |
| Alfa Muhihi, PhD |
Not provided
Not provided
| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
Not provided
Not provided
| OTHER |
| Columbia University | OTHER |
Not provided
Not provided
Not provided
None (Open label)
Not provided
| 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. |
|
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 |
| At two months of taking each regimen |
| Adherence | Percentage pill count of the number of supplements taken | At two months of taking each regimen |
| Africa Academy of Public Health |
| Principal Investigator |
| Andrea 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 |
| D008670 |
| Metals |