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Growth Hormone Administration and the Human Immune System
NCT00663611 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00663611
The ClinicalTrials.gov registry entry for NCT00663611 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00663611 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00663611?
The interventions under investigation include: Placebo (DRUG), Norditropin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00663611?
This trial is sponsored by National Institute on Aging (NIA), which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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