- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00436631
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients will have contacted either Dr. Kossoff or Dr. Cervenka either via referral or self-referral.
Inclusion: over 18 years of age, at least weekly seizures (or 4 per month), tried at least 2 medications for your seizures, have email and fax access, are not very underweight or have high cholesterol, have not had status epilepticus (seizure lasting over 30 minutes) in the past 6 months, and have not tried the Atkins diet before or the ketogenic diet within the past year. All patients will need to have a local primary care doctor or neurologist willing to be available in case of emergencies. You and your local physician both need to speak and write in English and patients MUST be in the United States to participate. The patient (NOT a caregiver) must be the person to email the investigators - a family member cannot be the contact person.
If the patient agrees, we will send and they will fax back within 2 weeks:
- Signed consent
- Signed note from their neurologist/primary care provider (attached)
- 6 months of medical records to confirm their qualification
- 3-day food record (can be emailed by the patient)
- Labs (CBC, CMP, fasting lipid profile, urine calcium, urine creatinine, urine hcG (if female) (form attached)
After that, we will send information on how to do the diet via email, they will maintain monthly calendars, and after 3 months we will decide if the diet is helpful. After that time point, they can continue it on their own with periodic followup with either us or their local neurologist.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adults aged 18 years or older.
- Patients must consent for themselves (NOT a family member doing this).
- Patients need to be willing to perform the induction phase of the diet.
- Patients must have access to an email account and fax machine.
- Persisting, countable seizures (> 1 per week or 4 times per month) despite previous treatment with two or more antiepileptic drugs.
- Patients with coronary heart disease, cerebrovascular disease, peripheral vascular disease, atherosclerosis, prior myocardial infarctions, or renal dysfunction will be excluded.
Exclusion Criteria:
- Patients previously exposed to the Atkins diet (for more than one week) will be excluded.
- Patients who had tried the ketogenic diet within the past year will be excluded.
- Patients with non-epileptic seizures (pseudoseizures) will be excluded.
- Patients that are pregnant or become pregnant during the study will be excluded.
- Patients must have a local English-speaking neurologist or primary care provider willing to sign a form stating they are available for any emergencies, considering some patients may be a far distance away.
- Patients must live in the United States.
- Patients must not have a history of status epilepticus within the past 6 months.
- Patients with a BMI that is below 18.5 will be excluded.
- Patients must speak and write in English.
- Patients must be from the United States.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: diet
|
Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially.
This is a 3-month study of this diet.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Anfaldshyppighed
Tidsramme: 3 måneder
|
3 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Tolerability (ability to create and maintain ketosis), cholesterol, weight
Tidsramme: 3 months
|
3 months
|
Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).
Tidsramme: 3 months
|
3 months
|
Ketosis (measured by urine)
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Kossoff EH, McGrogan JR, Bluml RM, Pillas DJ, Rubenstein JE, Vining EP. A modified Atkins diet is effective for the treatment of intractable pediatric epilepsy. Epilepsia. 2006 Feb;47(2):421-4. doi: 10.1111/j.1528-1167.2006.00438.x.
- Kossoff EH, Rowley H, Sinha SR, Vining EP. A prospective study of the modified Atkins diet for intractable epilepsy in adults. Epilepsia. 2008 Feb;49(2):316-9. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NA_00008471
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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