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NCT00663611 · ClinicalTrials.gov registry record · Phase 1
Growth Hormone Administration and the Human Immune System
A Phase 1 study of Healthy Volunteers, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT00663611: Completed Phase 1 study of Healthy Volunteers, sponsored by National Institute on Aging (NIA).
NCT00663611 is a Phase 1 study of Healthy Volunteers that has completed, run by National Institute on Aging (NIA). The registered enrollment target is 66 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00663611, a Phase 1 study of Healthy Volunteers, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in the body s production of growth hormone, which helps regulate human development and may contribute to the health of the immune system. Researchers are interested in studying whether growth hormone, given as an infusion over time, can improve the function of the immune system and other body systems associated with good health. Objectives: \- To study the effects of growth hormone administration on the immune systems of healthy men. Eligibility: \- Healthy men between 25 and 50 years of age. Design: * This protocol will involve three separate studies: Study I, Study IB, and Study II. Participants in Study I and Study IB may participate in Study II as directed by the researchers. * Participants will be screened with a full medical history and physical examination, and will provide blood, urine, and stool samples; have a glucose tolerance test; and have other tests as required by the researchers. * Participants will have an infusion pump with a small catheter inserted beneath the skin to administer the study chemicals (either growth hormone or placebo). * Study I and Study IB participants will receive pulses of growth hormone through the infusion pump at regular intervals to monitor the body s response to the hormone. Study IB participants will receive a higher dose of growth hormone than Study I participants. * Throughout the study period, all participants will have frequent blood and urine tests, as well as tests of glucose tolerance and metabolism, imaging studies, and other tests as required by the researchers. * Study II participants will be divided into two groups. The first group will receive pulses of either growth hormone or placebo infusion at intervals throughout the day for 4 wee
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Norditropin
Study Locations (1)
Maryland
- National Institute of Aging, Clinical Research Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2006-10-19 |
| Est. Completion | 2014-10-06 |
| Phase | Phase 1 |
What the finished NCT00663611 record still lists
NCT00663611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00663611 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00663611 about?
NCT00663611 is a clinical study titled "Growth Hormone Administration and the Human Immune System". Background: \- In elderly individuals, an age-associated decline in the immune system s ability to function is believed to contribute to increased incidence of infection, autoimmune disorders, and cancer. This decline in immune system function may be related to the decline in the body s production ...
What is the current status of trial NCT00663611?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2006-10-19. Estimated completion is 2014-10-06.
What conditions does trial NCT00663611 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT00663611?
The interventions under investigation include: Placebo (DRUG), Norditropin (DRUG).
Who is sponsoring clinical trial NCT00663611?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00663611 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00663611's enrollment target sits among peer trials
66 101st of 283 higher than 181 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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