Virutubisho

Phase 2

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202210764744357
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 216

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified