Open Stanford, California, USA: Potential Role of Tetrahydrobiopterin Deficiency in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Stanford Medicine: Potential Role of Tetrahydrobiopterin Deficiency in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

You are invited to participate in a research study of chronic, unexplained fatigue, which is a kind of fatigue that does not improve with rest. Medically unexplained fatigue is a symptom of Chronic Fatigue Syndrome and it may be present in other chronic diseases and conditions. Our overarching goal is to learn what causes this form of fatigue, how to diagnose and treat patients with this debilitating symptom, and how to differentiate the mechanisms of illness in ME/CFS from other complex multi-system illnesses. This research study is specifically designed to address whether individuals with fatigue have a deficiency of the cofactor tetrahydrobiopterin, or BH4.


Please confirm that none of these conditions apply to you:

• I am below the age of 18.
• I am pregnant or lactating.
• I have been diagnosed with an inborn error of metabolism that requires me to restrict protein intake. (e.g. hyperphenylalaninemia.)
• I have severe anemia, active bleeding, or other medical conditions whereby the removal of extra blood tubes can endanger my well-being.
• I have a chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HPC).
• I have been diagnosed with cancer, chronic renal disease, or other clinically significant medical issue that could explain my ME/CFS symptoms.
• I am currently using illegal or illicit substance(s).

Link

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Also from the email about this:

We are also recruiting healthy volunteers to participate in this study. Please note that healthy volunteers must not have any blood relations with you. If you know anyone who might be interested, please feel free to forward this email to them.

Instructions for Healthy Volunteers:

• Visit our Studypage to learn more and fill out an interest form. Studypage Interest form for The Potential Role of Tetrahydrobiopterin Deficiency in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
• If you want to enroll in the study, go to this link - "Link to enroll in The Potential Role of Tetrahydrobiopterin (BH4) Deficiency in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)".
• Send an email to bh4_research @ stanford.edu stating you are a healthy volunteer and have completed the above two steps.

 

Non-specific cohort of fatiguing conditions so I'm skeptical on what they will really be able to learn about "how to differentiate the mechanisms of illness in ME/CFS from other complex multi-system illnesses."

From the study page interest form...
"This study is open to individuals with fatigue who have one or more other diagnoses, including:

• postural orthostatic tachycardia syndrome (POTS)
• Ehlers Danlos Syndrome
• multiple sclerosis
• fibromyalgia
• post-treatment Lyme disease
• Gulf War Illness
• systemic lupus erythematosus
• dermatomyositis
• Sjogren’s Syndrome
• other autoimmune disease. This is not an exhaustive list, but persistent fatigue must be a chief complaint."

 

I have ME and “persistent fatigue” doesn’t even break my top ten.

 

This appears to be open to anyone in the USA for the first stage, which is sending a DNA sample by mail. A subset of the participants will be asked to come to Stanford for the second stage, but as far as I can tell, they don't require you be able to travel there if you just want to do the first stage.

Not totally clear, but I applied, and it didn't disqualify me for marking that I am unable to travel to Stanford. It did also ask if I'd be willing to do further participation by mail, so maybe the second stage can be done remotely as well.

From the consent document:

 

The ME doctor I saw 30 years ago didn't require fatigue as a symptom. His diagnosis was based on history, 20+ years experience, onset, length of illness and most importantly r/o other illnesses first.