Clinical trial NCT05515913: Nutritional Status and ASD Severity of Autistic Spectrum Disorder Children in Addis Ababa, Ethiopia; Case Control Study
Official title: Assessment of Nutrient Profile, Nutritional Status, Development and Severity of Children With Autistic Spectrum Disorder in Comparison With Typically Developing Children in Addis Ababa, Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autistic Spectrum Disorder
Keywords: Autistic spectrum disorder (ASD)
Typically developing children (TDC)
Nutritional status
Nutrient intake
Urine Iodine
Autistic severity
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population of this study were school-aged (i.e. 4-17 years old) children with ASD residing in Addis Ababa, Ethiopia. The study was conducted in one of the two selected autism center in Addis Ababa Ethiopia , one of the two autism centers in Ethiopia. Controls were selected from typically developing children's population of the same area as of ASD population.

Brief summary: The study conducts a case control analysis of the nutritional status and intake of autistic spectrum disorder diagnosed children as compared to typically developing children in Addis Ababa, Ethiopia. It included analysis of anthropometric measurements, three days food diary food intake, urinary iodine analysis, childhood autism rating scale diagnosis, food frequency and eating behavior questioner and proximate analysis of one day major meals of selected subjects.

Detailed description: Sample population was Addis Ababa city in which subjects were selected from one of the two autism centers in the country. Random sampling method was applied to select subject from the total enrolled children in the center using Ryan 2013 sample size calculation formula.

Subjects already diagnose with autistic spectrum disorder that didn't have any other chronic disease that affect diet and nutrition were included in the study. Subjects were selected randomly from each grade level in the center. They were registered and taken for data collection. Sample and Data was collected with the help of each child's center caregiver and parent. Childhood autism rating scale diagnosis, eating behavior analysis were analyzed for the ASD and anthropometric indices Z scores, urine iodine concentration, three days food diary analysis, major meals proximate analysis, food frequency and dietary diversity was assessed and compared to typically developing children in Addis Ababa.

Data entry and analysis was conducted using Emergency Nutrition Assessment software, Microsoft excel and Statistical Package for the Social Sciences software.

Eligibility criteria: Inclusion Criteria:

* Children already diagnosed with ASD
* school aged children (4-18 years old)

Exclusion Criteria:

* children with chronic illnesses ( such as cancer..)
* children taking heavy medications that may affect diet and nutrition

Primary outcomes:
measure: Body Mass Index for age z-scores
timeFrame: 1 day
measure: Height for age z-scores
timeFrame: 1 day
measure: Weight for age z-scores
timeFrame: 1 day
measure: Zinc intake using three days food diary questioner
timeFrame: 5 days
measure: Energy intake using three days food diary questioner
timeFrame: 5 days
measure: Protein intake using three days food diary questioner
timeFrame: 5 days
measure: Lipid intake using three days food diary questioner
timeFrame: 5 days
measure: Carbohydrate intake using three days food diary questioner
timeFrame: 5 days
measure: Calcium intake using three days food diary questioner
timeFrame: 5 days
measure: Iron intake using three days food diary questioner
timeFrame: 5 days
measure: Thiamine intake using three days food diary questioner
timeFrame: 5 days
measure: Vitamin C intake using three days food diary questioner
timeFrame: 5 days
measure: Vitamin B2 intake using three days food diary questioner
timeFrame: 5 days
measure: Niacin intake using three days food diary questioner
timeFrame: 5 days
measure: Vitamin A intake using three days food diary questioner
timeFrame: 5 days
measure: Urine iodine concentration of children
timeFrame: 2 month
measure: Autism symptom severity of children using Childhood Autism rating Scale diagnosis
timeFrame: 2 days
Secondary outcomes:
measure: energy intake using proximate analysis of one day major meals
timeFrame: 2 months
measure: Ash intake using proximate analysis of one day major meals
timeFrame: 2 months
measure: Lipid intake using proximate analysis of one day major meals
timeFrame: 2 months
measure: protein intake using proximate analysis of one day major meals
timeFrame: 2 months
measure: Carbohydrate intake using proximate analysis of one day major meals
timeFrame: 1 week
measure: frequency of food group consumption using food frequency questioner
timeFrame: 5 days
measure: dietary diversity score of children using three days food diary
timeFrame: 5 days
measure: frequency of food refusal in children using a questioner
timeFrame: 5 days
measure: frequency of sensitivity to food
timeFrame: 5 days
measure: frequency of gastrointestinal symptoms
timeFrame: 5 days
measure: frequency of food allergic reactions
timeFrame: 5 days
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa Science and Technology University
Study officials:
affiliation: Addis Ababa Science and Technology University
name: Feven Yirgu Tamire
role: PRINCIPAL_INVESTIGATOR
References: