O'Mega Man Study: an investigation of fish oil and micronutrient supplementation on aggressive behaviour in a sample of inmates in a NSW Correctional Centre

Effect of fish oil and micronutrient supplementation on aggressive behaviour of adult offenders: a Randomised Control Trial (RCT) pilot and feasibility study

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000734763

Enrollment

136

Registered

2013-07-02

Start date

2013-07-09

Completion date

2013-07-09

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to assess the feasibility of conducting a placebo controlled trial in the Corrective Services setting and also to generate pilot data for use in the application of funding for a multi-centre trial in due course. It is expected that the fish oil plus micronutrients supplemented group will have reduced aggressive behaviour comapred to the placebo group.

Interventions

Tuna Oil capsules ( 3 x 1g capsules per day for 16 weeks) AND Multi-vitamins and minerals (1 tablet per day for 16 weeks) The multi-vitamins tablet contains the following: Vitamin A (as retinyl palmitate) 750 IU Thiamin hydrochloride (vitamin B1) 50mg Riboflavin (vitamin B2) 20mg Nicotinic acid (vitamin B3) 10mg Nicotinamide (vitamin B3) 200mg Pantothenic acid (as calcium salt) (vitamin B5) 100mg Pyridoxine hydrochloride (vitamin B6) 50mg Cyanocobalamin (vitamin B12) 100mcg Ascorbic acid (vitamin C) 50mg Vitamin D3 (cholecalciferol) 100 IU Vitamin E (as d-alpha tocopherol acid succinate) 25 IU Betacarotene 3mg Biotin 20mcg Folic Acid (vitamin B9) 150mcg Calcium (as amino acid chelate) 10mg Cobalt (as chloride) 25mcg Copper (as amino acid chelate) 6mcg Lithium (as carbonate) 140mcg Magnesium (as L-aspartate and phosphate) 7.6mg Manganese (as sulphate) 93mcg Potassium (as L-aspartate) 2mg Potassium (as di-hydrogen phosphate) 13.6mg Zinc (as gluconate) 1.3mg Zinc (as sulphate) 7.6mg Amino-benzoic acid 20mg Choline bi-tartrate 50mg Inositol 25mg Scutellaria lateriflora (Equiv. dry herb) 100mg Valeriana officinalis (Equiv. dry root) 100mg L-Glutamine 50mg Lysine hydrochloride 10mg Betaine hydrochloride 10mg Administered simultaneously One week supply will be provided in a blister pack and the empty blister pack is returned prior to receiving the next week's supply

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Resident of South Coast Correctional Centre and minimum stay of 4 months

Exclusion criteria

Erythrocyte EPA and DHA of greater than 6% of total fatty acids

Outcome results