Recombinant human growth hormone for Gulf War Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Michael E. DeBakey VA Medical Center, Houston, TX
Gulf War Syndrome+3 More
Recombinant human growth hormone - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a placebo-controlled, double-blind, parallel, Randomized Controlled Trial of 6 months of Growth Hormone Replacement Therapy (GHRT) vs. placebo in Veterans with a history of Gulf War Illness (GWI) and Adult Growth Hormone Deficiency (AGHD). The investigators hypothesize that GHRT will reduce truncal fat mass percentage measured by DEXA (primary outcome). This could provide those veterans with GWI and AGHD a novel therapeutic option (GHRT). The study will also examine the feasibility and safety of a larger efficacy trial.

Eligible Conditions

  • Gulf War Syndrome
  • Adult Onset Growth Hormone Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gulf War Syndrome

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 6 months

6 months
Assessment of quality of life
Cardiometabolic Risk Factors
Change in truncal fat mass from baseline to six months
Depression, Anxiety, and Stress
Fatigue
Lean body mass
Pain Intensity and Interference

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Gulf War Syndrome

Trial Design

2 Treatment Groups

Growth Hormone Replacement Therapy
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

36 Total Participants · 2 Treatment Groups

Primary Treatment: Recombinant human growth hormone · Has Placebo Group · Phase 2

Growth Hormone Replacement Therapy
Drug
Experimental Group · 1 Intervention: Recombinant human growth hormone · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recombinant human growth hormone
2003
Completed Phase 4
~210

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Michael E. DeBakey VA Medical Center · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2007First Recorded Clinical Trial
2 TrialsResearching Gulf War Syndrome
50 CompletedClinical Trials

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
910 Previous Clinical Trials
5,981,730 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
1 Patients Enrolled for Gulf War Syndrome
United States Department of DefenseFED
759 Previous Clinical Trials
202,124 Total Patients Enrolled
5 Trials studying Gulf War Syndrome
315 Patients Enrolled for Gulf War Syndrome
Ricardo Jorge, MDPrincipal InvestigatorBaylor College of Medicine

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are younger than or equal to 64 years old.
You have a diagnosis of Gulf War Illness.
You are able and willing to provide informed consent to participate in the study and complete the study protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.