Anorexia nervosa Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
Stratified randomization (SIMS computer generated) will assign to the control group of 500kcal/ day or the treatment group 1200kcal/ day. Stratification for %IBW 55-69% and 70 ? 75%, and enteral versu
electrolytes should be replaced as outlined in the British National Formulary (2009). Once biochemistry and vital signs are stable total calories can then be increased by 200kcal/day until estimated c
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children who are admitted to one of the specialist centers and have been diagnosed with an eating disorder (DSM IV, 2005) 2. Aged 8 -16 years old 3. Have a weight for height Ideal Body Weight (IBW) 0.5kg in the past week 5. Requiring nutritional rehabilitation enteral or oral
Exclusion criteria
Exclusion criteria: 1. Excluded if fed via parenteral nutrition 2. Those patients that have any medical condition that may influence biochemistry or cardiovascular parameters above expected in anorexia nervosa i.e. diabetes Type 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular evaluation QT Interval ? Baseline pre refeeding (24-48hrs) and then four day post refeeding. QT interval will be measured by a standard 12 lead, adjusted for age. The QT interval will be measured from the initial downward deflection of the QRS complex to the end of the T-wave. QT dispersion will be calculated with a minimum of 9 leads in which the QT interval could be measured. QT dispersion was defined as the difference between the longest and shortest QT interval in one ECG recording. QT intervals will be corrected by heart rate (QTc) according to Bazett?s formula. However, the Bazett formula has flaws when calculating QTc in bradycardic and tachycardic patients, therefore Framingham formula will also calculate QTc. Power Statement QT Interval ? an effect size of 25ms difference between the control and treatment group 4 days post feeding is deemed significant with a standard deviation of 20ms (Cooke 1994, Swenne 2000,Mont 2003, Olivares 2005, Roche 2005, Ulger 2006, Nahshoni 2007, DiVasta 2010). Altman?s Normagram Standardized difference 1.0 = Target difference 25ms Standard Deviation 20ms It was calculated that 20 participants would be required in each arm, using a two sample t-test to compare the two groups, in order to have an 80% chance of detecting a significant difference after four days of refeeding when comparing the two arms to identify a difference of 25ms (Q-T interval) at the 5% level of significance, assuming the standard deviation of 20ms (Q-T interval). | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical 1. Phosphate: Baseline pre refeeding serum phosphate level is to be obtained by a venopuncture. If serum phosphate is within normal range then fasting serum phosphate will be obtained on days 2, 4, 6, 10 and 14 post refeeding. However, if serum phosphate level is low then biochemistry must be monitored daily. 2. Serum glucose, insulin, magnesium, potassium, calcium, sodium Serum monitoring of the above biochemistry will be obtained by venopuncture, to be taken pre refeeding. If serum biochemistry is within normal range then fasting biochemistry will be obtained on days 1, 2, 4, 6, 10 and 14 post refeeding. However, if serum biochemistry levels are deranged then biochemistry must be monitored daily until supplementation is effective. Other Measurements 1. Anthropometrics (weight for height %, BMI) determined by using standard protocol and weight for height computer data system; weight to be measured every 3 days. 2. Resting heart rate ? Baseline pre-refeeding resting supine heart rate will be measured using the ECG. It is suggested that patients should be rested for 10 minutes and achieve a regular pulsatile waveform for 20seconds prior to the recording. 3. Blood pressure ? measured at least twice day 4. Temperature ? daily 5. Urine ketone ? day 1 and to continue if ketones present Nutritional Data The nutritional analysis will be an essential component in the overall data analysis and therefore food record charts must be completed accurately hence the need for appropriate training of research collaborators. Food record charts will be analysed using DietPlan 5 computer system. 15 essential nutrients will be analysed over the 14 days of admission. | — |
Countries
United Kingdom
Outcome results
None listed