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Table 1 Summary of the study outcome measures and methods

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

Variables

Methods

Blood analysisa

 25(OH)D

Serum: Siemens ADVIA Centaur Vitamin D Total assay

 RBC fatty acids

Erythrocytes: Shimadzu GC-17A flame-ionisation gas chromatography (Rydalmere, NSW, Australia)

 Calcium

Serum: Siemens Dimension Vista® System. CA Flex® reagent cartridge, Cat. No. K1023

 Albumin

Serum: Siemens Dimension Vista® System. ALB Flex® reagent cartridge, Cat. No. K1013

 Iron studies

Ferritin, serum: Siemens Dimension Vista® System. FERR Flex® reagent cartridge, Cat. No. K6440

Iron, serum: Siemens Dimension Vista® System. IRON Flex® reagent cartridge, Cat. No. K3085

Total iron binding capacity, serum: Siemens Dimension Vista® System. TIBC Flex® reagent cartridge, Cat. No. K3084

 Vitamin B12

Serum: Siemens Dimension Vista® System. B12 Flex® reagent cartridge, Cat. No. K6442

 Folate

Serum: Siemens Dimension Vista® System. FOL Flex® reagent cartridge, Cat. No. K6444

 Full blood count

Whole blood: Sysmex XE-5000â„¢ Automated Haematology System

 Vitamin A

Plasma:, Shimadzu Prominence Modular HPLC System. Cat. No. LC-20A. The assay was developed at Massey University

Questionnaires

 Primary outcome measures

  Sociocommunicative functioning

Social Responsiveness Scale-second edition (SRS-2) [73]. Completed by caregiver at Massey University

  Sensory problems

Sensory Processing Measure (SPM) [75]. Completed by caregiver at Massey University

  Problem behaviours

Aberrant Behaviour Checklist-Community (ABC-C) [78]. Completed by caregiver at Massey University

 Secondary outcome measure

  Gastrointestinal symptoms

A questionnaire and diaries completed by caregiver

 Other measures

  Sociodemographics

Completed by caregiver

  Medical history

Completed by caregiver

  Dietary assessments

Dietary Index Children’s Eating (DICE). Completed by caregiver

Feeding issues and mealtime behaviours (Behavioural Paediatrics Feeding Assessment Scale, BPFAS). Completed by caregiver

Four-day estimated food diary. Completed by caregiver. Analysed using FoodWorks 2007 (Xyris Software)

Nutritional supplements and special dietary regimens. Completed by caregiver

  Sun exposure and skin colour

Completed by caregiver

  Medication/supplement use/incidence of adverse events and supplement compliance

Diary completed by caregiver

  Anthropometry

Weight: Tanita electronic scale; Height: Stadiometre; measured by researcher at Massey University

  1. 25(OH)D 25-hydroxyvitamin D, HPLC high-performance liquid chromatography, RBC red blood cell
  2. aAll blood samples are collected and analysed at the North Shore and Waitakere Hospitals