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NCT Number: NCT01006811

Use of the Modified Atkins Diet in Infantile Spasms

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).

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Key information

Conditions

Infantile Spasms Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases Spasms, Infantile

Age range

6 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110049, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Atkins diet

Dietary Supplement

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 names: Dietary treatment

Modified Atkins diet

Other

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 names: Dietary treatment

Primary outcomes

  1. seizure reduction as per parental reports

    Time frame: 3 months

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

Secondary outcomes

  1. adverse effects of the diet as per parental reports

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Acronym: ADIS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Nov 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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