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Use of the Modified Atkins Diet in Infantile Spasms

NCT ID: NCT01006811

Last Updated: 2010-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).

Detailed Description

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Conditions

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Infantile Spasms

Keywords

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West syndrome Hypsarrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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modified Atkins diet

Group Type EXPERIMENTAL

modified Atkins diet

Intervention Type DIETARY_SUPPLEMENT

Modified Atkins Diet administration

1. Carbohydrates intake 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.

modified Atkins diet

Intervention Type OTHER

Modified Atkins Diet administration

1. Carbohydrates intake 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.

Interventions

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modified Atkins diet

Modified Atkins Diet administration

1. Carbohydrates intake 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.

Intervention Type DIETARY_SUPPLEMENT

modified Atkins diet

Modified Atkins Diet administration

1. Carbohydrates intake 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.

Intervention Type OTHER

Other Intervention Names

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Dietary treatment Dietary treatment

Eligibility Criteria

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Inclusion Criteria

1. Age: 6 months to 3 years.
2. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day.
3. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam).

Exclusion Criteria

1. Known or suspected inborn error of metabolism, as evidenced by: 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, and positive results on urine neurometabolic screening tests.
2. Motivational or psychosocial issues in the family which would preclude compliance
3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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All India Institute of Medical Sciences

Principal Investigators

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Suvasini Sharma, MD, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Sheffali Gulati, MD

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Locations

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All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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Sharma S, Sankhyan N, Gulati S, Agarwala A. Use of the modified Atkins diet in infantile spasms refractory to first-line treatment. Seizure. 2012 Jan;21(1):45-8. doi: 10.1016/j.seizure.2011.08.009. Epub 2011 Sep 14.

Reference Type DERIVED
PMID: 21920781 (View on PubMed)

Other Identifiers

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ADIS

Identifier Type: -

Identifier Source: org_study_id