|
ISRCTN
|
ISRCTN41104834
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Nutrition as a modifiable causal factor in anti-social behaviours
|
|
Scientific title
|
Nutrition as a modifiable causal factor in anti-social behaviours: a randomised, placebo controlled, double blind trial
|
|
Acronym
|
PINUP (PrIson NUtrition Project)
|
|
Serial number at source
|
GR078667MA
|
|
Study hypothesis
|
Supplements of vitamins, minerals and essential fatty acids will reduce anti-social behaviour in young offenders in prison.
|
|
Lay summary
|
|
|
Ethics approval
|
Received from South East Research Ethics Committee on the 11th September 2006 (ref: 06/MREC01/47)
|
|
Study design
|
Randomised placebo controlled double blind trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Anti-social behaviour in prison
|
|
Participants - inclusion criteria
|
16 - 21 year old male offenders in prison.
|
|
Participants - exclusion criteria
|
1. Chronic medical conditions
2. Psychotropic medication
|
|
Anticipated start date
|
01/02/2009
|
|
Anticipated end date
|
31/12/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
1000
|
|
Interventions
|
Food supplements (minerals, vitamins and essential fatty acids):
1. Forceval (Alliance Pharma plc): contains vitamin A (750 µg), vitamin D (10 µg), vitamin B1 (1.2 mg), vitamin B2 (1.6 mg), vitamin B6 (2 mg), vitamin B12 (3 µg), vitamin C (60 mg), vitamin E (10 mg), vitamin K1 (120 µg), biotin (100 µg), nicotinamide (18 mg), pantothenic acid (4 mg), folic acid (400 µg), calcium (100 mg), iron (12 mg), copper (2 mg), magnesium (30 mg), zinc (18 mg), iodine (140 µg), manganese (3 mg), potassium (4 mg), phosphorus (77 mg), selenium (50 µg), chromium (200 µg), molybdenum (250 µg). 1 capsule per day p.o. (by mouth).
2. Equazen: contains gamma linolenic acid (45 mg), eicosapentaenoic acid (EPA) (951 mg), docosahexaenoic acid (DHA) (147 mg), vitamin E (8.4 mg), magnesium (60 mg). 3 x 854 mg capsules daily by mouth.
Total duration of treatment: 4 months (maximum)
Total duration of follow-up: 1 month (for all treatment arms)
|
|
Primary outcome measure(s)
|
Governor's reports (of violence and other offences), measured after 4 months treatment.
|
|
Secondary outcome measure(s)
|
1. Blood levels of micronutrients, measured after 4 months treatment
2. Cambridge Neuropsychological Test Automated Battery (CANTAB) measures of impulsivity, attention, measured after 4 months treatment
3. Heart rate variability changes, measured after 4 months treatment
|
|
Sources of funding
|
The Wellcome Trust (UK) (grant ref: 078667)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
John
Stein
|
|
Address
|
Physiology, Anatomy and Genetics
Parks Road
|
|
City/town
|
Oxford
|
|
Zip/Postcode
|
OX1 3PT
|
|
Country
|
United Kingdom
|
|
Sponsor
|
University of Oxford (UK)
|
|
Address
|
Wellington Square
|
|
City/town
|
Oxford
|
|
Zip/Postcode
|
OX1 3XP
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1865 270011
|
|
Fax
|
+44 (0)1865 280467
|
|
Email
|
richard.lewicki@admin.ox.ac.uk
|
|
Sponsor website:
|
http://www.ox.ac.uk/
|
|
Date applied
|
05/01/2009
|
|
Last edited
|
06/01/2009
|
|
Date ISRCTN assigned
|
06/01/2009
|
