Pregnancy Related
Conditions
Keywords
Acceptability, Multiple Micronutrient Supplementation, Iron, IFA, Tanzania
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTIron Folic Acid Tablets with 60 mg of iron
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
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 from the time of randomization.
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
NONE
Masking description
None (Open label)
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 the study area 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 formulation | At two months of taking each regimen | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Most preferred formulation | At four months (after taking both regimens) | 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. |
| Side Effects of formulation | At two months of taking each regimen | 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 |
| Adherence | At two months of taking each regimen | Percentage pill count of the number of supplements taken |
Contacts
CONTACTEmily R Smith, ScD, MPH
CONTACTChristopher R Sudfeld, ScD, ScM
PRINCIPAL_INVESTIGATORBlair Wylie, MD, MPH
Columbia University
PRINCIPAL_INVESTIGATORHonorati Masanja, PhD
Ifakara Health Institute
PRINCIPAL_INVESTIGATORAlfa Muhihi, PhD
Africa Academy of Public Health
PRINCIPAL_INVESTIGATORAndrea 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