Trial Outcomes & Findings for Gulf War Illness Inflammation Reduction Trial (NCT NCT02506192)

Last Updated: 2024-12-10

Results Overview

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,

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

0, 8, and 16 weeks

Results posted on

2024-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	42	41
Overall Study COMPLETED	41	40
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Gulf War Illness Inflammation Reduction Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified-Release Prednisone n=42 Participants 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	Placebo n=41 Participants 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	Total n=83 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49.7 years STANDARD_DEVIATION 4.0 • n=5 Participants	52.2 years STANDARD_DEVIATION 6.4 • n=7 Participants	51.0 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	40 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	41 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 8, and 16 weeks

Outcome measures

Outcome measures
Measure	Modified-Release Prednisone n=42 Participants 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	Placebo n=41 Participants 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
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks baseline	40.8 units on a scale Standard Deviation 9.2	41.5 units on a scale Standard Deviation 9.9
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks 8 weeks	43.5 units on a scale Standard Deviation 9.6	43.4 units on a scale Standard Deviation 9.8
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks 16 weeks	40.8 units on a scale Standard Deviation 8.3	41.4 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 0, 8, and 16 weeks

MPQ asks questions about sensory pain, affective pain, pain now, and typical pain

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 8, and 16 weeks

MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 8, and 16 weeks

CFQ asks questions about cognitive symptoms such as attention, concentration, and memory

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 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,

Outcome measures

Outcome measures
Measure	Modified-Release Prednisone n=42 Participants 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	Placebo n=41 Participants 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
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks baseline	40.8 units on a scale Standard Deviation 13.3	40.4 units on a scale Standard Deviation 12.8
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks 8 weeks	42.4 units on a scale Standard Deviation 13.2	43.1 units on a scale Standard Deviation 11.9
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks 16 weeks	40.1 units on a scale Standard Deviation 13.2	42.7 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: 0, 8, and 16 weeks

Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald R Bach, PhD, Principal Investigator

Minneapolis VA Health Care System

Phone: (612)467-6315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place