Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: diet
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Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially.
This is a 3-month study of this diet.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Frequenza delle crisi
Lasso di tempo: 3 mesi
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3 mesi
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Tolerability (ability to create and maintain ketosis), cholesterol, weight
Lasso di tempo: 3 months
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3 months
|
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Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).
Lasso di tempo: 3 months
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3 months
|
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Ketosis (measured by urine)
Lasso di tempo: 3 months
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3 months
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NA_00008471
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .