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NCT00097474 · ClinicalTrials.gov registry record · Phase 2
Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00097474 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 57 participants.
The verdict
NCT00097474, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones. The cause of jet lag is not known, but various hormones, including cortisol and melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's internal rhythms. This study will test whether taking cortisol, melatonin, or both can help re-establish the body's day-night cycle and result in less jet lag. People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study: * Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time and the destination) * Destination between 30 and 50 latitudes (approximately Cairo to London) * Evening flight (5 PM to midnight) with morning arrival * Remaining abroad at least 4-10 days Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not overweight) and must not be taking medicines that affect sleep or cortisol or melatonin levels. Prospective participants are screened with a medical history, blood tests, and check of blood pressure, height, and weight. Pre-flight Procedures Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine sample the week before the flight to test for pregnancy. On the day of the flight, the participants do not collect saliva or fill out sleep logs or questionnaires. They are given two bottles with study medication. One bottle, labeled "AM," c
Interventions
- DRUG Placebo
- DRUG Melatonin
- DRUG Hydrocortisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2004-12-21 |
| Est. Completion | 2007-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00097474
The ClinicalTrials.gov registry entry for NCT00097474 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00097474 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00097474 about?
NCT00097474 is a clinical study titled "Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag". This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones. The caus...
What is the current status of trial NCT00097474?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2004-12-21. Estimated completion is 2007-11-14.
What interventions are being tested in trial NCT00097474?
The interventions under investigation include: Placebo (DRUG), Melatonin (DRUG), Hydrocortisone (DRUG).
Who is sponsoring clinical trial NCT00097474?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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