Open Label of Clinical Trial of Sulforaphane in Children With Autism
Ключови думи
Резюме
Описание
Sulforaphane (SF) is an isothiocyanate found in high levels in crucifers belonging to the family Brassicaceae (including broccoli, cabbage, cauliflower, brussels sprouts, Chinese cabbage and turnips). Many previous studies have documented that consumption of these vegetables is associated with a reduced risk of cancer (lung, breast, colon, rectum, and prostate).(Juge et al. 2007) The mechanism of action of these beneficial effects is believed to be due to the ability of SF to up-regulate genes that improve cellular response to oxidative stress, inflammation, DNA-damaging electrophiles, and radiation.(Singh et al. 2014) In a recent small, randomized controlled trial in children with autism, SF was shown to have beneficial effects on aberrant and social behavior.(Singh et al. 2014) The mechanism of action of this beneficial effect has not been established in children with ASD. Our primary goal is to examine changes in urinary metabolites in children with autism who receive SF to determine if changes in behavior are associated with changes in urinary metabolites.
Дати
| Последна проверка: | 02/28/2019 |
| Първо изпратено: | 01/10/2016 |
| Очаквано записване подадено: | 01/11/2016 |
| Първо публикувано: | 01/12/2016 |
| Изпратена последна актуализация: | 03/03/2019 |
| Последна актуализация публикувана: | 03/05/2019 |
| Действителна начална дата на проучването: | 12/31/2015 |
| Приблизителна дата на първично завършване: | 04/30/2016 |
| Очаквана дата на завършване на проучването: | 08/31/2016 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: SF
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: SF Sulforaphane (SF) will be administered in an approximate dosage of 1 µmol SF/lb (2.2 kg µmol/kg) body weight. This dosage roughly approximates the dosage that was used in the Singh et al, (2014; PNAS) clinical trial of sulforaphane in male adolescents and adults with autism. The sulforaphane will be supplied as glucoraphanin (GR)-enriched broccoli seed extract tablets (manufacturing details follow). Each active tablet will contain 125 mg broccoli seed extract (containing 37 µmol GR, which is equivalent to about 15 µmol SF), 50 mg dried broccoli sprouts (a source of myrosinase, the enzyme that converts GR to SF), 15 mg ascorbic acid, 55.90 mg microcrystalline cellulose, and other minor GRAS excipients used for tablet forming.
The total dose per day will depend of study participants' body weight. | Dietary Supplement: SF Children with ASD will receive Sulforaphane in this study |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 5 Years Да се 5 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD. - ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation). - Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: - Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. |
Резултат
Първични изходни мерки
1. Urinary metabolites [3 month]
2. Behavior Measures [3 months]
