Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006811
Other study ID # ADIS
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 1, 2009
Last updated November 19, 2010
Start date October 2009
Est. completion date November 2010

Study information

Verified date November 2010
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 3 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
modified Atkins diet
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.
Other:
modified Atkins diet
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.

Locations

Country Name City State
India All India Institute of Medical Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months No
Secondary adverse effects of the diet as per parental reports 3 months Yes
See also
  Status Clinical Trial Phase
Withdrawn NCT02299115 - Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms Phase 3
Completed NCT02885389 - Molecular Genetics in Infantile Spasms N/A
Completed NCT01828437 - Addition of Pyridoxine to Prednisolone in Infantile Spasms Phase 3
Recruiting NCT01858285 - Genetics of Epilepsy and Related Disorders
Completed NCT00552045 - Epilepsy Phenome/Genome Project
Completed NCT02220114 - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy N/A
Completed NCT02954887 - Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) Phase 3
Completed NCT02092883 - Evaluation of Neuroinflammation in Children With Infantile Spasms Phase 4
Completed NCT01723787 - Genetic Studies in Patients and Families With Infantile Spasms
Withdrawn NCT01413711 - An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms Phase 4
Terminated NCT00442104 - Open-label Extension to Protocol 1042-0500 Phase 2
Completed NCT00441896 - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Phase 2
Completed NCT01575639 - Prednisolone in Infantile Spasms- High Dose Versus Usual Dose Phase 3
Withdrawn NCT01549288 - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy Phase 2/Phase 3
Not yet recruiting NCT06315829 - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Completed NCT01073579 - Sabril Patient Registry N/A
Completed NCT02953548 - Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) Phase 3
Completed NCT00001325 - Metabolic Abnormalities in Children With Epilepsy N/A
Completed NCT00968136 - Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study N/A