Modified Atkins Diet in Childhood Epilepsy (mAD)

This study has been completed.
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00836836
First received: February 3, 2009
Last updated: June 20, 2011
Last verified: June 2011
  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.

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

  1. Carbohydrates intake will be restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
  2. Fats (e.g. cream, butter, oils, ghee) encouraged.
  3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
  4. Clear carbohydrate-fluids not restricted.
  5. Calcium and multivitamin supplementation will be provided.
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

  1. Carbohydrates intake will be restricted to 10 grams/ day. (Carbohydrate values of various food items will be explained in detail, and exchange lists provided. Four 2.5 grams carbohydrate exchange items will be allowed in a day.)
  2. Fats (e.g. cream, butter, oils, ghee) encouraged.
  3. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted.
  4. Clear carbohydrate-fluids not restricted.
  5. Calcium and multivitamin supplementation will be provided.
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836836

Locations
India
All India Institute of Medical sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Council of Scientific and Industrial Research, India
Investigators
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 April 14, 2014