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Table 2 Schedule of enrolment, intervention, and assessment

From: Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial

 

Study period

 

Enrolment

Allocation

Post allocation

Timepoint

t−2

t−1

t0

tbaseline

t6-month

t12-month

w1–52

Enrolment:

 Initial eligibility screen

♦

      

 Informed consent

♦

      

 Nutritional deficiencies screen

 

♦

     

Allocation

  

♦

    

Interventions:

 Vitamin D

   

♦

♦

♦

 

 Omega-3 LCPUFAs

   

♦

♦

♦

 

 Vitamin D + omega-3 LCPUFAs

   

♦

♦

♦

 

 Placebo

   

♦

♦

♦

 

Assessments:

 Nutritional biomarkers

  Serum 25(OH)D

   

♦

♦

♦

 

  RBC fatty acids

   

♦

 

♦

 

  Calcium

   

♦

♦

♦

 

  Albumin

   

♦

♦

♦

 

  Iron studies

   

♦

   

  Vitamin B12

   

♦

   

  Folate

   

♦

   

  Full blood count

   

♦

   

  Vitamin A

   

♦

   

 Primary outcome

  Social Responsiveness Scale-2

   

♦

 

♦

 

  Sensory Processing Measure

   

♦

 

♦

 

  Aberrant Behaviour Checklist

   

♦

 

♦

 

 Secondary outcome

  Gastrointestinal symptoms

   

♦

 

♦

♦

 Dietary assessment

  Dietary Index Children’s Eating

   

♦

 

♦

 

  Behavioural Paediatric Feeding Assessment Scale

   

♦

 

♦

 

  4-day food diary

   

♦

   

  Nutritional supplements and dietary regimen

   

♦

   

 Other assessments

  Sociodemographics

   

♦

   

  Medical history

   

♦

   

  Sun exposure and skin colour

   

♦

   

  Compliance and adverse events diary

      

♦

  1. 25(OH)D 25-hydroxyvitamin D, t timeline, w week, LCPUFA long chain polyunsaturated fatty acid
  2. According to the SPIRIT statement: Defining Standard Protocol Items for Clinical Trials