Role of Ketogenic Diet in SSPE

NCT05152771 | Unknown DMC

• 1 other identifier: 2021-6491-19410.
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

SSPE is a progressive neurodegenerative disorder occurring after measles infection and is potentially life-threatening.Measles infection remains endemic in Pakistan especially in the lower socioeconomic population where the vaccine coverage is low. The ketogenic diet has been used in a large number of diseases especially intractable epilepsies in children and also in certain neurodegenerative disorders like Parkinson's and Alzheimer's in adults. Some of the case reports from India and the USA have reported the beneficial results of ketogenic diet(KD) not only in the control of myoclonic jerks of SSPE but also in stopping and reversing the progress of the disease. There is a definite need to conduct a multi-center trial of KD to establish its effectiveness in SSPE. At the Aga khan university, the investigators have an experienced team who have been using KD for the last 9 years for intractable epilepsy. At AKU the investigators currently have 4 patients on board for the past 4 months, with diagnosed SSPE on Low Glycemic Index Diet and showing some improvement in their seizure and motor control. Based on these reports, for a poor measles control country like Pakistan, there is a need to work further in order to establish evidence for KD therapy as a treatment for SSPE. The findings of the proposed study will serve as a hope for the improvement of quality of life of patients suffering from SSPE which is a devastating disease with almost 100% mortality .

Conditions

SSPE

Keywords

Ketogenic Diet; Progressive Neurological Disorder; Intractable Epilepsy

Outcome Measures

Primary Outcomes (1)

• Seizure control

  frequency and severity will be measured through a seizure record diary, daily number of seziures will be averaged over a month and monthly record will be evaluated as percentage increase or decrease in 3 months intervals

  for a period of 6 months .

Secondary Outcomes (3)

• cognitive Change ,

  base line, after 6 months of study then after and one year of study.

• behavioral Change

  base line, after 6 months of study then after and one year of study

• motor developmental Change

  base line, after 6 months of study then after and one year of study

Study Arms (1)

Ketogenic Diet

OTHER

This will be a prospective cohort study. All families with children who have been newly diagnosed with confirmed SSPE (based on Dyken's Criteria) will be approached to start the low glycemic index diet (liberalized kind of KD). A thorough dietary history will be taken from the parents/caregivers, and they will be counseled by a trained dietitian on the diet, all pros and cons, and the format. After the verbal agreement, formal consent will be taken from the parent/ caregiver for initiation of the diet.

Other: KETOGENIC DIET

Interventions

KETOGENIC DIET OTHER

This will be a prospective cohort study. All families with children who have been newly diagnosed with confirmed SSPE (based on Dyken's Criteria) will be approached to start the low glycemic index diet (liberalized kind of KD). A thorough dietary history will be taken from the parents/caregivers, and they will be counseled by a trained dietitian on the diet, all pros and cons, and the format. After the verbal agreement, formal consent will be taken from the parent/ caregiver for initiation of the diet. These patients are usually already admitted in the hospital for initial diagnosis and management. Therefore the initiation of the diet will be in the hospital during their admission if the parents/ caregivers agrees. A minimum of 2-3 days would be required to train the parents/caregivers.

Also known as: LOW GLYCEMIC INDEX DIET

Ketogenic Diet

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having at least one member of the family residing with the patient who can read and understand directions in Urdu and /or Sindhi.

You may not qualify if:

• Parents not agreeing to start the diet.
• Age less than 2 years or over 15 years.
• Patients who are already being given immune modulators.
• Any other associated co-morbidity.
• Patients having difficulty in swallowing and parents not allowing a nasogastric tube.
• Totally uneducated family with no one who can read or write and understand directions in Urdu and/ or Sindhi.

Sponsors & Collaborators

• Aga Khan University: lead
• National Institute of Child Health, Karachi, Pakistan: collaborator

Related Publications (2)

• Rafique A, Amjad N, Chand P, Zaidi SS, Rana MS, Ahmed K, Ibrahim S. Subacute sclerosing panencephalitis: clinical and demographic characteristics. J Coll Physicians Surg Pak. 2014 Aug;24(8):557-60.

  PMID: 25149833 RESULT

• Ibrahim SH, Amjad N, Saleem AF, Chand P, Rafique A, Humayun KN. The upsurge of SSPE--a reflection of national measles immunization status in Pakistan. J Trop Pediatr. 2014 Dec;60(6):449-53. doi: 10.1093/tropej/fmu050. Epub 2014 Sep 16.

  PMID: 25232151 RESULT

Related Links

• Jafri SK, Kumar R, Ibrahim SH. Subacute sclerosing panencephalitis - current perspectives. Pediatric Health Med Ther. 2018;9:67-71

MeSH Terms

Conditions

Subacute Sclerosing Panencephalitis; Drug Resistant Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Measles; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Epilepsy

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shahnaz H Ibrahim, MBBS ;FCPS

  AKU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahnaz H Ibrahim, MBBS;FCPS

CONTACT

+923002119347; shahnaz.ibrahim@aku.edu

Hira Farooq, NUTRITION

CONTACT

+923152566548; hira.farooq@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share