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Fig. 1 | Trials

Fig. 1

From: Ketogenic diet in the treatment of epilepsy in children under the age of 2 years: study protocol for a randomised controlled trial

Fig. 1

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure; schedule of enrollment, interventions and assessments. *At baseline, all procedures should be done before randomisation. **Ketogenic diet group only. (X) – As indicated/appropriate. 1Complete physical includes weight, length, head circumference, general examination. 2Tests to be done: haematology – full blood count (FBC); biochemistry – liver function tests, renal function tests, calcium, urate, glucose, phosphate, vitamin D, selenium, zinc, cholesterol, carnitine profile and beta-hydroxybutyrate; urinalysis – organic acids, urine calcium and creatinine ratio. Results must be received prior to randomisation. 3Home monitoring urine dipstick and blood spot ketones done twice a day and recorded in Seizure Diary (only KD arm). 4Special assay or procedure – blood sample to be analysed by Simon Heales at ICH

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Trials

ISSN: 1745-6215