Modified Atkins Diet in Childhood Epilepsy (mAD)
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Purpose
Seizures are a frequent cause of morbidity in the pediatric age group. Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and/or regression, and cognitive impairment. The ketogenic diet is a well known treatment option for refractory epilepsy. However it is very restrictive and requires strict weighing of foods. The modified Atkins diet is a dietary therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. Early studies have demonstrated efficacy and safety.There are no randomized trials evaluating the efficacy of the modified Atkins diet in children with refractory epilepsy. Hence this study has been planned to investigate whether there are clear benefits in terms of seizure control in children with refractory epilepsy who are treated with the modified Atkins diet, versus controls.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Childhood Epilepsy |
Other: Modified Atkins diet |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial. |
- Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Tolerability and the adverse effects of the modified Atkins diet. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 |
Other: Modified Atkins diet
Modified Atkins Diet administration
Other Name: Dietary intervention
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.
Exclusion Criteria:
- Known or suspected inborn error of metabolism
Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following:
- a history of parental consanguinity
- prior affected siblings
- unexplained vomiting
- intermittent worsening of symptoms
- recurrent episodes of lethargy
- altered sensorium, or ataxia
- hepatosplenomegaly on examination
And/ or 2 or more of the following biochemical abnormalities
- High blood ammonia (>80mmol/L)
- High arterial lactate (>2 mmol/L)
- metabolic acidosis (pH <7.2)
- hypoglycaemia (blood sugar <40 mg/dl)
- abnormal urinary aminoacidogram
- presence of reducing sugars or ketones in urine
- positive results on urine neurometabolic screening tests
- Motivational or psychosocial issues in the family which would preclude compliance
- Systemic illness- chronic hepatic, renal or pulmonary disease
Contacts and Locations| India | |
| 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 |
More Information
No publications provided by All India Institute of Medical Sciences, New Delhi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Suvasini Sharma, All India Institute of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00836836 History of Changes |
| Other Study ID Numbers: | ModAtkins |
| Study First Received: | February 3, 2009 |
| Last Updated: | June 20, 2011 |
| Health Authority: | India: Ministry of Health |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
Childhood epilepsy ketogenic diet |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013