Current Clinical Trials

Posted July 2017

A Clinical Trial of BioFe, Medical Food for the Dietary Management of Iron Deficiency

This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.

Iron deficiency is the most common, widespread, and costly nutritional disorder worldwide with the World Health Organization (WHO) stating that up to 2 billion people are iron deficient. There is a serious and widespread misconception that oral iron supplements are safe and effective at alleviating iron deficiency. In a recent Cochrane review of 67 clinical trials, women taking oral iron supplements had a mere 38%decreased risk of iron deficiency compared to placebo. On the contrary, these subjects had a 114%increased risk of side effects, the vast majority of which were associated with gastrointestinal (GI) disturbance.

In infants and children, iron deficiency impedes mental, motor, and auditory neuronal development leading to serious lifelong cognitive and physical deficiencies. In adults, iron deficiency, and associated iron deficiency anemia, cause extreme fatigue, decreased immune system function and increased susceptibility to infectious disease, reduced work capacity, dizziness, headaches, hair loss, and generalized reduced quality of life. Iron deficiency is also linked to Restless Leg Syndrome (RLS), adult hearing deficits, reduced strength, coordination, and endurance, anxiety, increased heart failure morbidity, decreased intellectual performance, and erectile dysfunction among many others conditions.

Most iron deficient people are not effectively treated by, or are intolerant to, oral iron supplements. Intravenous iron repletion drugs effective, but are also costly and onerous to deliver leading to both patient and payor dissatisfaction.

BioFe, Medical Food for Iron Deficiency is nutritional/Baker's yeast (Saccharomyces cerevisiae), expressing the Ferritin protein. Ferritin is an indispensable iron storage, transport and absorption protein normally produced at low levels by almost all living organisms. An illustrative example of the biology of the Ferritin/Iron complex is its presence in human breast milk, providing infants the natural biological iron required for rapid learning and development, without gastrointestinal upset. BioFe provides high level expression of Ferritin that is naturally complexed with iron during culture, is pasteurized, and dried.

Eligibility:
Ages Eligible for Study: 18 Years to 80 Years


Inclusion Criteria:

Moderate iron deficiency defined as transferrin saturation (TSAT) <20% and serum ferritin

Exclusion Criteria:

  • Female subjects who are pregnant, plan to become pregnant, or not willing to use an acceptable form of contraception (tubal ligation or otherwise be incapable of pregnancy, hormonal contraceptives, spermicide plus barrier, or intrauterine device).
  • Female subjects who are breastfeeding or plan to breastfeed after enrolling in the study.
  • Hemochromatosis or other iron storage disorders.
  • Hemoglobin below 8 g/dL.
  • Previous gastric bypass, sleeve gastrectomy, or gastric band surgery.
  • Currently on iron supplements and/or multivitamins containing iron (subjects may be pre-screened four weeks prior to the screening visit in order to stop/washout or switch to vitamins not containing iron). Currently on monoamine oxidase inhibitors (MAOIs) or Demerol.
  • Current diagnosis of asthma and is actively using anti-asthmatic therapy.
  • Smoking within two weeks of screening, current smoking, or anticipated smoking after enrolling in the study.
  • Active malignancy within one year of screening.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal.
  • Known positive Hepatitis B, Hepatitis C, or HIV-1/HIV-2.

Contact:
Darren Wolfe, PhD, 412-352-2498,
DWolfe@SideroBio.com
Erin Kraus, RN, 513-544-5030, ekraus@siderobio.com

Posted May 2017

The Emotional State in RLS.

RLS is associated with emotional distress and depression. Researchers at Yale are conducting a study that looks at this emotional stress and depression. The study is entirely an on-line questionnaire study. You will not need to talk to anyone to complete this study and it is completely anonymous. There is no way for the researchers or anyone to determine your identity even after you have completed the questionnaires. The first set of questions are to determine if you are eligible. We are looking to study primary RLS, that is RLS that occurs in the absence of diseases like, Parkinson disease, multiple sclerosis, severe neuropathy, end stage renal disease, schizophrenia, terminal cancer, and others. The questionnaires will take about 20 minutes to complete.

We also need a control group (Non- RLS subjects), so we ask that you identify someone without RLS that also does not have conditions, such as the ones mentioned above. For Non-RLS subjects filling out the questionnaires will take under 10 minutes.

Below are the instructions to get started.

ONLY the RLS subjects are requested to click on the the link below:
INSTRUCTIONS FOR RESTLESS LEGS SYNDROME SUBJECTS.
  • The RLS subjects survey is located at https://yalesurvey.qualtrics.com/jfe/form/SV_dmdwNeQFyEQU3wV The first page contains information about how data is collected and stored. Selecting “I consent to participate in this research study will initiate the survey.
  • Please read all instructions carefully to ensure that questions are answered appropriately.
  • Most of the questions included in the survey require a response. Do not skip any sections unless instructed to do so. You will be informed if you accidentally skip a required question.
  • The survey should be completed in one sitting. Expected time to complete is under 20 minutes.
ONLY the NON-RLS subjects are requested to click the link below:
INSTRUCTIONS FOR Non-RLS SUBJECTS.
  • The Non-RLS survey is located at https://yalesurvey.qualtrics.com/jfe/form/SV_bHProabY4tzpiip
  • The first page contains information about how data is collected and stored. Selecting “I consent to participate in this research study” will initiate the survey.
  • Please read all instructions carefully to ensure that questions are answered appropriately.
  • Most of the questions included in the survey require a response. Do not skip any sections unless instructed to do so. You will be informed if you accidentally skip a required question.
  • The survey should be completed in one sitting. Expected time to complete is under 10 minutes.

If you are interested in learning more about this study, please contact Dr. Brian Koo by:
Phone: (203) 932-5711 x 5416
Email: brian.koo@yale.edu

Posted May 2016

John W. Winkelman, MD, PhD, with the Sleep Disorders Clinical Research Program, Massachusetts General Hospital, is conducting a research study on the investigational use of intravenous (IV) iron with ferric carboxy maltose (Injectafer) for the treatment of RLS. Injectafer is approved for use by the U.S. Food and Drug Administration (FDA) to treat adult patients with iron deficiency anemia (IDA) but, it is not approved to treat RLS symptoms.

Qualified participants will receive two IV infusions (lasting at least 7.5 minutes) 5 days apart of either IV iron or placebo. Participants have an equal chance of getting iron or placebo. Neither you nor the study doctor will know which one you will get. If you are taking a medication for RLS, you will be asked to taper and discontinue it following the second IV infusion. You can only be taking one prescribed medication for RLS to be eligible for entry into this study.

The study will require a total of approximately 7 visits over 1 year to the MGH Sleep Disorders Clinical Research offices located in Boston, MA. This is a 1-year study with phone call follow-ups approximately every 6 weeks between in-clinic visits. You will be compensated for time and travel up to $350.00 for completion of the study.

Participation in this study is entirely voluntary, if you enroll, you can withdraw from the study at any time. All of the information that is learned from the study will be kept confidential. Your name and other personal information would not be attached to the study data. To maintain confidentiality, information from participation in the study would not be available for inclusion in your medical record.

If you are interested in participating in this study or learning more about it, please contact research coordinator, Leslie Mei by phone at 617-643-6026 or by email at lamei@partners.org. Please also share this information with family members who may be interested.

Posted March 2016

Does your child have discomfort in their legs that may interfere with their sleep? They may describe their symptoms as throbbing, pulling, creeping, pain or other abnormal sensations felt in the legs when lying down or sitting. Your child may be suffering from adolescent Restless legs Syndrome.

Worldwide Clinical Trials is conducting research studies to test an investigational medication for the treatment of adolescent RLS. You will receive the medication at no charge, an assessment by an RLS expert and compensation for participating in this research clinical trial. The studies will take place at the following locations Amherst (NY), Columbia (SC), Indianapolis (IN), Nashville (TN), Philadelphia (PA), Redwood City (CA), and San Diego (CA). Qualified participants will be compensated for time and travel. To qualify, participants must:

  • be 13-17 years of age
  • be diagnosed with RLS
  • have moderate-to-severe symptoms
  • have parent/legal guardian consent

If you are interested in learning more about this study, or to find out if you qualify call (520)-252-1908 or email Camilla.Alexander@wwctrials.com.

Posted January 2013

If you live in the New York City area, you may be eligible to participate in a new research opportunity.

We are conducting a research study to determine whether there are changes in the retinal structure of the eyes of individuals with Restless Legs Syndrome, also known as Willis-Ekbom Disease (WED/RLS) compared to individuals with Parkinson’s disease, multiple system atrophy, and healthy controls.

The study will take place at the New York University Langone Medical Center and will require one visit, lasting approximately 1-2 hours. The visit will include an initial screening and an eye exam. You will be asked to sit comfortably and to place your chin in a chin rest and to look into a machine that will take pictures of your optic nerve. The eye examination will take approximately 15 minutes and you will not feel anything while the machine takes pictures of your retina (the back of your eye).

There is no direct benefit to you or expense reimbursement available from your participation in the study. It is hoped that the knowledge gained will be of benefit to others in the future. Studies done for this research study are not a part of your regular medical care and will not be included in your medical record.

If interested, please contact Dr. Jose Martinez at Jose.Martinez@nyumc.org.

Further Reading

Clinical Trails: What to Know Before You Go

Inside: Important Information for those considering clinical trail participation

Read More