Modified Atkins Diet in Childhood Epilepsy (mAD)
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|ClinicalTrials.gov Identifier: NCT00836836|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Refractory Childhood Epilepsy||Other: Modified Atkins diet||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial.|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||March 2011|
Modified Atkins diet arm-In this arm, the children will start the modified Atkins diet after a 4-week baseline period, during which daily seizure log will be maintained. Anti-epileptic medications will remain unchanged during the 3 month trial period, unless the change in AED regimen is medically indicated; e.g. drug side effects or status epilepticus; in which case standard therapy will be provided.
Other: Modified Atkins diet
Modified Atkins Diet administration
Other Name: Dietary intervention
No Intervention: 2
No Intervention arm- After the 4-week baseline period, this group will receive their normal diet with no dietetic input, and remain on the same on-going antiepileptic medication for the 3 months. Anti-epileptic medications will remain unchanged during the 3 month trial period, unless the change in AED regimen is medically indicated; e.g. drug side effects or status epilepticus; in which case standard therapy will be provided.
At the end of three months, patients in this arm will be offered the option of the modified Atkins diet treatment.
This group will not receive any dietetic input
- Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group. [ Time Frame: 3 months ]
- Tolerability and the adverse effects of the modified Atkins diet. [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836836
|All India Institute of Medical sciences|
|New Delhi, Delhi, India, 110029|
|Principal Investigator:||Suvasini Sharma, MD||All India Institute of Medical Sciences, New Delhi|
|Study Director:||Sheffali Gulati, MD||All India Institute of Medical Sciences, New Delhi|
|Study Chair:||Anuja Agarwala, MSc||All India Institute of Medical Sciences, New Delhi|