A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months (NCT02364843) | Clinical Trial Compass
TerminatedNot Applicable
A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months
Stopped: PI has retired and had trouble recruiting babies
Canada2 participantsStarted 2016-02
Plain-language summary
This is the 5th in a series of physiological studies to determine the amino acid requirements of infants. There have been 4 studies to determine tyrosine, methionine, threonine and lysine requirements in infants when they are fed by parenterally (intravenously). Due to the new requirements of Health Canada for preparation of parenteral solutions, the investigators are starting the phase of the study that determines the enteral (oral) intake of threonine in 1 - 6 mo infants in the interim.
Who can participate
Age range
1 Month – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between ages 1 - 6 months
* Born between 32 and 43 weeks gestational age
* Clinically stable (normal vital signs and blood values)
* Fed by nasogastric (NG), jejunal (J or NJ), or gastric (G) tube
Exclusion Criteria:
* Infants will be excluded if they are receiving supplemental oxygen
* Mechanically ventilated
* Have any endocrine or genetic anomalies that affect protein or AA metabolism
* On medications that influence protein and AA metabolism (ex: corticosteroid therapy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of increasing threonine intakes on breath F13CO2 in enterally fed infants ages 1 - 6 months