Nutritional, Metabolic, Endocrine
Conditions
Interventions
Control MMS
Multiple micronutrients test dose 1
Multiple micronutrients test dose 2
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Non-pregnant cohort Women aged 18-35 years Not pregnant and not lactating Not intending to move away for 6 months Negative pregnancy test and not intending to get pregnant during study Able and willing (in the investigator’s opinion) to comply with all study requirements Pregnant women cohort Women aged 18-35 years Pregnant with singleton pregnancy from 14 to less than or equal to 20 weeks gestation Not intending to move away for 6 months Able and willing (in the investigator’s opinion) to comply with all study requirements
Exclusion criteria
Exclusion criteria: Non-pregnant women Known intolerance or allergy to constituents of IP Moderate or severe anaemia (Hb<8g/dL) or other nutritional conditions requiring immediate treatment Unwilling to substitute regular micronutrient supplements for the study product Pregnant women Known intolerance or allergy to constituents of IP Multiple pregnancy Moderate or severe anaemia (Hb<7g/dL) or other nutritional conditions requiring immediate treatment Unwilling to substitute regular micronutrient supplements for the study product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of optimal dosing of multiple micronutrient supplements (MMS) to correct micronutrient deficiencies among pregnant and non-pregnant women of reproductive age in Kilifi County, Kenya | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety of micronutrients described at different doses, including birth outcomes | — |
Countries
Kenya
Contacts
Public ContactCynthia Mauncho
Head of Communication
Outcome results
None listed