Modified Atkins Diet in Childhood Epilepsy

NCT00836836 | Completed Phase 2 DMC

• 1 other identifier: ModAtkins
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Childhood Epilepsy

Keywords

Childhood epilepsy; ketogenic diet

Outcome Measures

Primary Outcomes (1)

• Reduction in seizure frequency at 3 months in the two groups: the modified Atkins diet group, and the control group.

  3 months

Secondary Outcomes (1)

• Tolerability and the adverse effects of the modified Atkins diet.

  3 months

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

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

Interventions

Modified Atkins diet OTHER

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.

Also known as: Dietary intervention

1

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Seizures persisting daily or more than 7 per week despite the appropriate use of at least 3 anti-epileptic drugs.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Council of Scientific and Industrial Research, India: collaborator

Study Sites (1)

All India Institute of Medical sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (2)

• Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.

  PMID: 32588435 DERIVED

• Sharma S, Sankhyan N, Gulati S, Agarwala A. Use of the modified Atkins diet for treatment of refractory childhood epilepsy: a randomized controlled trial. Epilepsia. 2013 Mar;54(3):481-6. doi: 10.1111/epi.12069. Epub 2013 Jan 7.

  PMID: 23294191 DERIVED

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Suvasini Sharma, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Sheffali Gulati, MD

  All India Institute of Medical Sciences

  STUDY DIRECTOR

• Anuja Agarwala, MSc

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

IN (1)