ACTRN12611000334909招募中1 期
A study on children and adolescents with Prader-Willi syndrome, of Caralluma fimbriata extract and the placebo of maltodextrin/cabbage leaf, to determine any change in satiation on the markers of hyperphagia.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 17 Years（—）
- 性别
- All
入选标准
- •We will only include those with a confirmed diagnosis with any of the three types of deletion of PWS (listed above). PWS through FISH or DNA methylation analysis. All participants will be between the ages of 5 -17yrs This age group has been defined because typically the physical gross motor development has reached maturation and participants will be verbal and within the school system. This age allows for more constant parental supervision. Typical features within the inclusion criteria allow a child to function daily without medical intervention. therefore within healthy parameters. District: All recruited participants will be Australian and new Zealand citizens and will be willing to attend either the Melbourne clinical consultations at baseline, mid and post intervention period or define weight with a medical practitioner. New Zealand and interstate participants must gain paediatrition supervised anthropometric measures. Parent/Carers All participants will be under supervision. They must be within visual and auditory supervision in all” environments; except within the parameters of natural toileting and sleep. This supervision will come form parents and carers within the home environment. They will need to speak English and be able to identify their child’s appetite behaviours. They may consult with outside carers: Teacher’s aides - if in the position of direct supervisor. Special school facilitators placed in a position of direct supervisor. Respite workers placed in a position of direct one on one” supervision. Particpants We will include those people with PWS on Growth Hormone medication or natural therapies such as Coenzyme Q10, or fish oil. All participants will be healthy. Participants with PWS will still be considered healthy when they have any of the typical parameters defined below. Overweight within the 50 to 90 percentile Hypotonia (low muscle tone) and problems with strength, coordination and balance Developmental delay Growth Hormone (GH) deficiency Low sex steroids (testosterone and estrogen) Hypogonadism Sleep disturbances (not on a respirator) Temperature dysregulation High pain threshold Skin picking – cellulitis Hypopigmentation Dental problems and thick saliva Auditory difficulties or deafness. IQs within the range of 40 to 105 Those with learning issues. These may be difficulties in conceptual understanding, attention and short-term auditory memory. Autistic tendencies such as Obsessive Compulsive Disorder (OCD) behaviour and behavioural temper tantrums. Those with behaviour such as manipulation, possessive, stubbornness and stealing or lying related to food. Abnormalities in appetite regulating hormones ( eg. Ghrelin is elevated) Hyperphagia Minimal energy expenditure Slow metabolism. Participants from interstate throughout Australia and New Zealand are welcome.
排除标准
- •Those without a confirmed diagnosis of PWS.
- •Those with PWS who do not speak English.
- •Those with PWS and any of the conditions listed below:
- •Impaired Glucose Tolerance IGT. Those people with PWS who have a prevalence of glucose intolerance or are considered to have an impaired glucose metabolism.
- •Type 1 diabetes
- •Type 2 diabetes.
- •Chronic Asthma
- •Metabolic syndrome
- •Past indications of kidney dysfunction
- •Liver damage
- •Heart disease
- •Bariatric surgery.
- •Severe sleep-apnea.
- •Those using night respiratory aids for sleeping.
- •Those in psychiatric care.
- •Those with a recorded history related to their inability to vomit.
- •Those with a recorded history of reduced pain sensitivity.
- •Those people with PWS who are not under supervision.
- •Excluded medications
- •Seizure medications. IE: phenabarbitone.
- •Medications for ADHD. IE: Retelin.
- •Psychiatric condition medications such as Antidepressants IE: Trycyclics.
- •Testosterone
- •(Note: Because of puberty related issues with PWS drugs such as testosterone or oestrogen may have been implemented. These may confound the results.)
- •Carer exclusions
- •Carer who do not speak English
研究者
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