Nutritional Status and ASD Severity of Autistic Spectrum Disorder Children in Addis Ababa, Ethiopia; Case Control Study

Autistic Spectrum Disorder Clinical Trial

— ASD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515913
• Other study ID #: AASTUASD
• Status: Completed
• Start date: August 14, 2021
• Est. completion date: February 8, 2022

Study information

• Verified date: August 2022
• Source: Addis Ababa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 8, 2022
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Spectrum Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Nutritional status
Nutritional status of children as analyzed by anthropometric indices was under study

Behavioral:
• Eating behavior
The eating behavior of ASD children as analyzed by frequency of refusal of new food, sensitivity to food, food allergy and gastrointestinal systems was under study

Other:
• Urine iodine concentration
the 24 urine iodine concentration of all subjects was under study
• Nutrient intake
The nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study
• Dietary assessment
The food frequency and dietary diversity of all subjects as analyzed by food frequency questioner, dietary diversity score and food variety score was under study
• Childhood autism rating scale
The autistic severity of ASD diagnosed children was under study as analyzed by childhood autism rating scale diagnosis

Locations

Country	Name	City	State
Ethiopia	Addis Ababa Science and Technology University	Addis Ababa

Sponsors (1)

Lead Sponsor	Collaborator
Addis Ababa University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index for age z-scores	Body Mass Index and age will be combined to report Body mass index for age z-score in Kg/m2 for age in months	1 day
Primary	Height for age z-scores	Height and age will be combined to report height for age z-scores in centimeter for age in months	1 day
Primary	Weight for age z-scores	weight and age will be combined to report weight for age z-scores in kg for age in months	1 day
Primary	Zinc intake using three days food diary questioner	Three days food diary questioner will be used to report intake of zinc in mg/day	5 days
Primary	Energy intake using three days food diary questioner	Three days food diary questioner will be used to report intake of energy in kcal/day	5 days
Primary	Protein intake using three days food diary questioner	Three days food diary questioner will be used to report intake of protein in gm/day	5 days
Primary	Lipid intake using three days food diary questioner	Three days food diary questioner will be used to report intake of lipid in gm/day	5 days
Primary	Carbohydrate intake using three days food diary questioner	Three days food diary questioner will be used to report intake of carbohydrate in gm/day	5 days
Primary	Calcium intake using three days food diary questioner	Three days food diary questioner will be used to report intake of calcium in mg/day	5 days
Primary	Iron intake using three days food diary questioner	Three days food diary questioner will be used to report intake of Iron in mg/day	5 days
Primary	Thiamine intake using three days food diary questioner	Three days food diary questioner will be used to report intake of Thiamine in mg/day	5 days
Primary	Vitamin C intake using three days food diary questioner	Three days food diary questioner will be used to report intake of vitamin C in mg/day	5 days
Primary	Vitamin B2 intake using three days food diary questioner	Three days food diary questioner will be used to report intake of vitamin B2 in mg/day	5 days
Primary	Niacin intake using three days food diary questioner	Three days food diary questioner will be used to report intake of niacin in mg/day	5 days
Primary	Vitamin A intake using three days food diary questioner	Three days food diary questioner will be used to report intake of vitamin A in mg/day	5 days
Primary	Urine iodine concentration of children	Urine iodine concentration of children in µg /L	2 month
Primary	Autism symptom severity of children using Childhood Autism rating Scale diagnosis	Childhood autism rating scale assessed by total raw scores by age. for age 0-12, scores of 15-29.5 indicate limited behavior related to autism, score of 30-36.5 indicate mild to moderate level of behavior related to autism, score 37-60 indicate sever level behavior related to autism. for age 13 years and older, 15-27.5 indicate limited behavior related to autism, score of 28-34.5 indicate mild to moderate level of behavior related to autism, score 35-60 indicate sever level behavior related to autism.	2 days
Secondary	energy intake using proximate analysis of one day major meals	proximate analysis of one day major meals will be used to report intake of energy in k cal /100gm	2 months
Secondary	Ash intake using proximate analysis of one day major meals	proximate analysis of one day major meals will be used to report intake of Ash in gm/100gm	2 months
Secondary	Lipid intake using proximate analysis of one day major meals	proximate analysis of one day major meals will be used to report intake of lipid in gm/100gm	2 months
Secondary	protein intake using proximate analysis of one day major meals	proximate analysis of one day major meals will be used to report intake of protein in gm/100gm	2 months
Secondary	Carbohydrate intake using proximate analysis of one day major meals	proximate analysis of one day major meals will be used to report intake of carbohydrate in gm/100gm	1 week
Secondary	frequency of food group consumption using food frequency questioner	percentage of children consuming from each food groups using a food frequency questioner	5 days
Secondary	dietary diversity score of children using three days food diary	consumption of 1-3 food groups is scored as low dietary diversity score, consumption of 4-5 food groups is scored as medium dietary diversity score, consumption of >5 food groups is scored as high dietary diversity score.	5 days
Secondary	frequency of food refusal in children using a questioner	frequency is scored as never to seldom, mild and sever	5 days
Secondary	frequency of sensitivity to food	frequency is scored as never to seldom, mild and sever	5 days
Secondary	frequency of gastrointestinal symptoms	frequency is scored as never to seldom, mild and sever	5 days
Secondary	frequency of food allergic reactions	frequency is scored as never to seldom, mild and sever	5 days