Curcumin, Resveratrol, and Stinging Nettle as Treatments for Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Average Veterans Rand 12-Item Health Survey (VR-12) Physical Functioning Score
研究概览
简要总结
This project's objective is to identify effective treatments for Gulf War Illness (GWI). The project tests three potential treatments: curcumin, stinging nettle, and resveratrol. The project uses a decentralized clinical trial (DCT) design in which individuals can participate from anywhere in the United States. Recruitment efforts will be designed to obtain a geographically and demographically diverse study sample.
详细描述
The project is funded by the Congressionally Directed Medical Research Programs (CDMRP) of the U.S. Department of Defense.
The study uses a prospective, pseudo-randomized, placebo-controlled, blinded, within-person clinical trial design. The trials are conducted decentralized, with all protocols performed remotely. Three-hundred individuals will be recruited in the study.
Recruitment for this study will come from a database of participant who have agreed to be contacted about future studies from our previous studies. Participants will also be recruited through the Gulf War Illness Clinical Trials and Intervention Consortium (GWICTIC) through our collaboration with Nova Southeastern University. The Consortium includes a database of individuals with Gulf War Illness who had agreed to be contacted for research studies. No other information will be shared with Nova Southeastern University unless specified and agreed upon. We will also use social media advertisements in partnership with High Level Marketing to recruit for this trial.
In accordance with the Institute of Medicine (IOM) 2014 guidance, participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have other exclusionary medical conditions.
All potential participants will fill out a online screening survey to assess eligibility. If they are deemed eligible for consent, participants will undergo a zoom meeting with a member of the study staff to sign the consent form. During that meeting, the study staff will explain the consent form in detail and answer any questions about the study or the consent form. The consenting process will follow the same procedure as typically done in face-to-face consenting, and the consent form will be digitally signed during or within 24 hours after the meeting. After providing informed consent, participants will take a post-consent survey to confirm eligibility before entering the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant, the study PI, and the main research team will be blinded.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In accordance with the Institute of Medicine (IOM) 2014 guidance, participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. The case definitions will be used for inclusionary screening purposes.
- •Inclusion Criteria:
- •Meets Kansas GWI Case Definition
- •Meets CDC GWI Case Definition
- •Able to commit to a 10-month study
排除标准
- •Currently involved in an experimental treatment study
- •Abnormal liver function values
- •Abnormal kidney function values
- •Currently pregnant
- •Blood clotting disorder (contraindicated with all three botanicals)
- •Reported diagnosis of diabetes with an A1C greater than 9
- •The use of contraindicated medications (see below):
- •Anticoagulant medications (such as warfarin, heparin, etc.)
- •Tacrolimus (Prograf)
- •Cancer medications (Alkylating agents, antitumor antibiotics, Topoisomerase I inhibitors, Tamoxifen)
研究组 & 干预措施
Gulf War Veterans, Curcumin
All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures.
Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.
干预措施: Curcumin (Dietary Supplement)
Gulf War Veterans, Resveratrol
All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures.
Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.
干预措施: Resveratrol (Dietary Supplement)
Gulf War Veterans, Stinging Nettle
All GWI Veterans will undergo the same screening and experimental procedures. Participants must meet both the Kansas and CDC (Centers for Disease Control and Prevention) Case Definitions of GWI. Participants must have been deployed to the Persian Gulf Region during the 1990-1991 Gulf War, meet symptom domain criteria, and not have exclusionary medical conditions. This trial tests three interventions, which are all tested independently. Participants will receive only one of the three interventions. The curcumin, resveratrol, and stinging nettle trials all follow the same design and procedures.
Participants will complete one month of baseline, eight months of capsules, and one month of endline measurements.
干预措施: Stinging Nettle (Dietary Supplement)
结局指标
主要结局
Average Veterans Rand 12-Item Health Survey (VR-12) Physical Functioning Score
时间窗: This outcome will be assessed weekly, for up to 44 weeks.
Veterans Rand 12-Item Health Survey (VR-12) Physical Functioning Score (PFS) will be assessed via an online survey. The PFS will be assessed on a 7-32 point scale, with higher scores indicating better health.
Average Veterans Rand 12-Item Health Survey (VR-12) Mental Functioning Score
时间窗: This outcome will be assessed weekly, for up to 44 weeks.
Veterans Rand 12-Item Health Survey (VR-12) Mental Functioning Score (MFS) will be assessed via an online survey. The MFS will be assessed on a 6-33 point scale, with higher scores indicating better health.
次要结局
- Patient Global Impression of Change (PGIC)(This outcome will be assessed weekly, for up to 44 weeks.)
- Number needed to treat (NNT)(This outcome will be assessed once, through study completion, an average of 44 weeks.)
研究者
Jarred Younger
Professor
University of Alabama at Birmingham