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Clinical Trials/PACTR202210764744357
PACTR202210764744357
Not yet recruiting
Phase 2

Optimizing nutrient requirement for maternal supplementation among women of reproductive age in Kenya

niversity of Oxford0 sites216 target enrollmentOctober 13, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford
Enrollment
216
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 13, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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