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Use of the Modified Atkins Diet in Infantile Spasms (ADIS)

Primary Purpose

Infantile Spasms

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

modified Atkins diet

About this trial

This is an interventional treatment trial for Infantile Spasms focused on measuring West syndrome, Hypsarrhythmia

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Motivational or psychosocial issues in the family which would preclude compliance
Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease

Sites / Locations

All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified Atkins diet

Arm Description

Outcomes

Primary Outcome Measures

seizure reduction as per parental reports

seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms

Secondary Outcome Measures

adverse effects of the diet as per parental reports

Full Information

NCT ID

NCT01006811

First Posted

November 1, 2009

Last Updated

November 19, 2010

Sponsor

All India Institute of Medical Sciences, New Delhi

1. Study Identification

Unique Protocol Identification Number

NCT01006811

Brief Title

Use of the Modified Atkins Diet in Infantile Spasms

Acronym

ADIS

Official Title

Efficacy and Tolerability of the Modified Atkins Diet in Patients With Infantile Spasms: a Pilot Study.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infantile Spasms

Keywords

West syndrome, Hypsarrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

modified Atkins diet

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

modified Atkins diet

Other Intervention Name(s)

Dietary treatment

Intervention Description

Modified Atkins Diet administration 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.) Fats (e.g. cream, butter, oils, ghee) encouraged. Proteins (cheese, fish, eggs, chicken, soya products) unrestricted. Clear carbohydrate-fluids not restricted. Calcium and multivitamin supplementation will be provided.

Intervention Type

Other

Intervention Name(s)

modified Atkins diet

Other Intervention Name(s)

Dietary treatment

Intervention Description

Primary Outcome Measure Information:

Title

seizure reduction as per parental reports

Description

seizure control at the end of 3 months will be classified as: spasm free; > 50% reduction in spasms; and < 50% reduction in spasms

Time Frame

3 months

Secondary Outcome Measure Information:

Title

adverse effects of the diet as per parental reports

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 6 months to 3 years. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam). Exclusion Criteria: 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. Motivational or psychosocial issues in the family which would preclude compliance Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suvasini Sharma, MD, DM

Organizational Affiliation

All India Institute of Medical Sciences, New Delhi

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sheffali Gulati, MD

Organizational Affiliation

All India Institute of Medical Sciences, New Delhi

Official's Role

Study Director

Facility Information:

Facility Name

All India Institute of Medical Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110049

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

21920781

Citation

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.

Results Reference

derived

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Use of the Modified Atkins Diet in Infantile Spasms

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