Omega-3, vitamin D and Autism in children

Conditions

None listed

Brief summary

Internationally, prevalence of autism appears to be increasing but the cause is unknown. In New Zealand one child in every 100 is diagnosed with a condition on the autism spectrum. Both vitamin D and Omega-3 polyunsaturated fatty acids are known to play a number of roles in brain development and behaviour. The VIDOMA trial will investigate the effect of supplementing these important nutrients in the diet of 168 young children with autism spectrum disorder. Children will take the supplements for one year and investigators will measure changes in symptoms such as social-communicative functioning, sensory processing profile, problem behaviours and gastrointestinal symptoms..

Mazahery H, Conlon C, Beck KL, Kruger MC, Stonehouse W, Camargo CA, Meyer BJ, Tsang B, Mugridge O, von Hurst PR.

2016-06-2314 citations

10.1186/s13063-016-1428-8

Interventions

An RCT with 3 treatment arms: 1: Omega-3, high DHA (722mg) fish oil; 2xomega-3 (total DHA dose = 722mg/day) per day + 2xplacebo per day 2:Vitamin D3, 2000IU; 2xvitamin D3 (1000IU/capsule) per day + 2xplacebo per day 3: Omega-3 (722mg DHA) and vitamin D3 (2000IU); 2xomega-3 (total DHA dose = 722mg/day) per day+2xvitamin D3 (1000IU/capsule) per day All in gel capsules with tear-off nipple allowing oil to be mixed with food. Administered daily with food for 12 months. Compliance monitored with dia

An RCT with 3 treatment arms: 1: Omega-3, high DHA (722mg) fish oil; 2xomega-3 (total DHA dose = 722mg/day) per day + 2xplacebo per day 2:Vitamin D3, 2000IU; 2xvitamin D3 (1000IU/capsule) per day + 2xplacebo per day 3: Omega-3 (722mg DHA) and vitamin D3 (2000IU); 2xomega-3 (total DHA dose = 722mg/day) per day+2xvitamin D3 (1000IU/capsule) per day All in gel capsules with tear-off nipple allowing oil to be mixed with food. Administered daily with food for 12 months. Compliance monitored with diary and pill counting in returned bottles.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

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

Eligibility

Sex/Gender

All

Age

2 Years to 8 Years

Healthy volunteers

No

Inclusion criteria

Medical diagnosis of autism spectrum disorder, onset after 18 months of age

Exclusion criteria

Children with winter 25(OH)D concentration > 75 nmol/L (+10 nmol/L assay variation) and summer 25(OH)D concentration > 105 nmol/L (+10 nmol/L assay variation) at baseline

Outcome results