Pregnancy Related
Conditions
Keywords
Acceptability, Multiple Micronutrient Supplementation, Iron, Tanzania
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 30 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.
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 45 mg of elemental iron
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.
DIETARY_SUPPLEMENTMultiple Micronutrient Supplements with 60 mg of elemental iron
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.
Sponsors
George Washington University
Ifakara Health Institute
Harvard School of Public Health (HSPH)
Muhimbili University of Health and Allied Sciences
Africa Academy for Public Health
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Attending first ANC visit at the study clinic * Pregnant women ≤ 15 weeks of gestation * Aged ≥ 18 years * Intending to stay in Dar es Salaam 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of MMS formulations | At one month of taking each regimen, up to 3 months | Participant reported acceptability of each MMS formulation using Likert scales ranging from 1 (disliked a lot) to 5 (liked a lot). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Most preferred MMS formulation | At three months (after taking all three regimens) | 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. |
| Least preferred MMS formulation | At three months (after taking all three regimens) | 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. |
| Identification of MMS iron dosage | At three months (after taking all three regimens) | Percentage of participants that correctly identify their iron dose treatment order |
| Side effects of MMS formulations | At one month of taking each regimen, up to 3 months | The percentage of patients experiencing any side effect (diarrhea, heartburn, constipation, vomiting, nausea, leg cramps, lower back/pelvic pain) during each intervention period |
| Adherence | At one month of taking each regimen, up to 3 months | The percentage of days a participant takes a MMS pill out of the total number of days in the intervention period |
Countries
Tanzania
Contacts
PRINCIPAL_INVESTIGATORBlair Wylie, MD, MPH
Columbia University
PRINCIPAL_INVESTIGATORHonorati Masanja, PhD
Ifakara Health Institute
PRINCIPAL_INVESTIGATORAlfa Muhihi, PhD
Africa Academy for Public Health
PRINCIPAL_INVESTIGATORAndreas Pembe, MD, MMed, PhD, FCOG
Muhimbili University of Health and Allied Sciences
PRINCIPAL_INVESTIGATOREmily R Smith, ScD, MPH
The George Washington University
PRINCIPAL_INVESTIGATORChristopher R Sudfeld, ScD, ScM
Harvard University
Outcome results
None listed