Status:
ACTIVE_NOT_RECRUITING
Methionine Requirements During Healthy Human Pregnancy
Lead Sponsor:
University of British Columbia
Conditions:
Pregnancy Related
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
The current recommendations for dietary amino acid intake in pregnant women are based on calculations from requirements of adult men. The study aims to determine methionine requirements during early (...
Detailed Description
Pre-study day protocol: Participants will be asked to meet for a brief (1 hour) pre-study assessment in preparation for the study day. Participants' eligibility will be assessed during this time. Sub...
Eligibility Criteria
Inclusion
- Women who are 20-40 years of age. This includes women of reproductive age who have a low relative risk ratio of maternal or neonatal morbidities.
- Women pregnant with a singleton pregnancy.
- Women who are 11-20 or 31-40 weeks pregnant.
- In apparently good health. Subjects must not have pre-existing health conditions.
Exclusion
- Women who are not pregnant or who are pregnant with more than one fetus.
- Women who were pregnant in the 6 months before the current pregnancy
- Women with history of spontaneous abortion (within the last 6 months) or pre-term birth
- Women who are younger than 20 years of age and older than 40 years of age.
- Women with a metabolic, neurological, genetic or immune disorder likely to affect nutritional requirements or overall body metabolism.
- 5\. Women who depend on medication that affects normal metabolism. 6. Women experiencing severe nausea, food avoidance or vomiting throughout their pregnancy.
- 7\. Women allergic to eggs or egg protein. 8. Women classified as underweight (\<18.5 kg/m2), overweight (25-30 kg/m2) or obese (\>30 kg/m2).
- 9\. Women smoking cigarettes, taking illicit drugs, or consuming alcohol regularly during their pregnancy.
- 10\. Women who do not take a prenatal vitamin for the duration of their study period.
- 11\. Women who have lost weight (approximately 1.5kg or more) during their current pregnancy.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04326322
Start Date
September 14 2020
End Date
December 30 2025
Last Update
December 11 2024
Active Locations (1)
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1
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z4H4