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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.
During Desert Shield and Desert Storm (Aug 2, 1990 to July 31,1991) 696,841 United States Military personnel were deployed to the Kuwaiti Theater of Operations. Today approximately one-third of those veterans are suffering from GWI, an unexplained chronic multi-symptom illness. Evidence of chronic inflammation in veterans with GWI has emerged from previous observational studies. The goal of this trial is to determine if reducing the GWI-associated chronic inflammation is an effective treatment for GWI. This is a randomized, two group, placebo controlled, double blind clinical trial. The treatment group will receive a low dose (2x5mg) once a day of delayed-release prednisone (Rayos) for 8 weeks. The placebo group will receive matching placebo (2x5mg) once a day for 8 weeks. The primary outcome measure for this clinical trial is a change from baseline of HRQOL with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of GWI-associated biomarkers of inflammation, changes from baseline of GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and a change from baseline of HRQOL with respect to mental functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified-Release Prednisone | Experimental | Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm |
|
| Placebo | Placebo Comparator | Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified-Release Prednisone | Drug | Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks | The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status, | 0, 8, and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of McGill Pain Questionnaire-short Form (MPQ) Scores at 8 and 16 Weeks | MPQ asks questions about sensory pain, affective pain, pain now, and typical pain | 0, 8, and 16 weeks |
| Change From Baseline of Multidimensional Fatigue Inventory (MFI) Scores at 8 and 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald R Bach, PhD | Minneapolis Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Veterans Affairs Medical Center | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37319244 | Background | Bach RR, Rudquist RR. Gulf war illness inflammation reduction trial: A phase 2 randomized controlled trial of low-dose prednisone chronotherapy, effects on health-related quality of life. PLoS One. 2023 Jun 15;18(6):e0286817. doi: 10.1371/journal.pone.0286817. eCollection 2023. |
| Label | URL |
|---|---|
| link to citation | View source |
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After publication, all deidentified study data will be made available to other investigators upon request. Data sharing rule of the journal will apply.
After publication for as long as specified by the journal
Established investigators with legitimate scientific credentials
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified-Release Prednisone | Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm Modified-Release Prednisone: Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks |
| FG001 | Placebo | Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm Placebo: Placebo oral tablets (2x5mg) daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified-Release Prednisone | Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm Modified-Release Prednisone: Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks | The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status, | Posted | Mean | Standard Deviation | units on a scale | 0, 8, and 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 2x5mg MR-prednisone QD at bedtime | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald R Bach, PhD, Principal Investigator | Minneapolis VA Health Care System | (612)467-6315 | ronald.bach@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2013 | Oct 18, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 5, 2015 | Oct 18, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D005221 | Fatigue |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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double-blind, placebo-controlled
| Placebo | Drug | Placebo oral tablets (2x5mg) daily for 8 weeks |
|
|
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. |
| 0, 8, and 16 weeks |
| Change From Baseline of Cognitive Failures Questionnaire (CFQ) Scores at 8 and 16 Weeks | CFQ asks questions about cognitive symptoms such as attention, concentration, and memory | 0, 8, and 16 weeks |
| Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks | SF-36V MCS is a measure of HRQOL with respect to mental functioning. The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate MCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V MCS is a measure of HRQOL with respect to mental functioning and symptoms. Higher scores indicate better health status, | 0, 8, and 16 weeks |
| Change From Baseline of Gulf War Illness-associated Peripheral Blood Biomarkers | Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses | 0, 8, and 16 weeks |
Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm Placebo: Placebo oral tablets (2x5mg) daily for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Modified-Release Prednisone |
Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm Modified-Release Prednisone: Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks |
| OG001 | Placebo | Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm Placebo: Placebo oral tablets (2x5mg) daily for 8 weeks |
|
|
| Secondary | Change From Baseline of McGill Pain Questionnaire-short Form (MPQ) Scores at 8 and 16 Weeks | MPQ asks questions about sensory pain, affective pain, pain now, and typical pain | Not Posted | Jan 2026 | 0, 8, and 16 weeks | Participants |
| Secondary | Change From Baseline of Multidimensional Fatigue Inventory (MFI) Scores at 8 and 16 Weeks | MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. | Not Posted | Jan 2026 | 0, 8, and 16 weeks | Participants |
| Secondary | Change From Baseline of Cognitive Failures Questionnaire (CFQ) Scores at 8 and 16 Weeks | CFQ asks questions about cognitive symptoms such as attention, concentration, and memory | Not Posted | Jan 2026 | 0, 8, and 16 weeks | Participants |
| Secondary | Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks | SF-36V MCS is a measure of HRQOL with respect to mental functioning. The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate MCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V MCS is a measure of HRQOL with respect to mental functioning and symptoms. Higher scores indicate better health status, | Posted | Mean | Standard Deviation | units on a scale | 0, 8, and 16 weeks |
|
|
|
| Secondary | Change From Baseline of Gulf War Illness-associated Peripheral Blood Biomarkers | Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses | Not Posted | Jan 2026 | 0, 8, and 16 weeks | Participants |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | 2 matching placebo tablets QD at bedtime | 0 | 41 | 0 | 41 | 0 | 41 |
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| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| 16 weeks |
|