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

August 23, 2022 updated by: Feven yirgu Tamire, Addis Ababa University

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Addis Ababa, Ethiopia, 0000
        • Addis Ababa Science and Technology University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ASD ( autistic spectrum disorder)
Children already diagnosed with autistic spectrum disorder
Nutritional status of children as analyzed by anthropometric indices was under study
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
the 24 urine iodine concentration of all subjects was under study
The nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study
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
The autistic severity of ASD diagnosed children was under study as analyzed by childhood autism rating scale diagnosis
TDC (typically developing children)
Children within the typically development
Nutritional status of children as analyzed by anthropometric indices was under study
the 24 urine iodine concentration of all subjects was under study
The nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index for age z-scores
Time Frame: 1 day
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
Height for age z-scores
Time Frame: 1 day
Height and age will be combined to report height for age z-scores in centimeter for age in months
1 day
Weight for age z-scores
Time Frame: 1 day
weight and age will be combined to report weight for age z-scores in kg for age in months
1 day
Zinc intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of zinc in mg/day
5 days
Energy intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of energy in kcal/day
5 days
Protein intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of protein in gm/day
5 days
Lipid intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of lipid in gm/day
5 days
Carbohydrate intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of carbohydrate in gm/day
5 days
Calcium intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of calcium in mg/day
5 days
Iron intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of Iron in mg/day
5 days
Thiamine intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of Thiamine in mg/day
5 days
Vitamin C intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of vitamin C in mg/day
5 days
Vitamin B2 intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of vitamin B2 in mg/day
5 days
Niacin intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of niacin in mg/day
5 days
Vitamin A intake using three days food diary questioner
Time Frame: 5 days
Three days food diary questioner will be used to report intake of vitamin A in mg/day
5 days
Urine iodine concentration of children
Time Frame: 2 month
Urine iodine concentration of children in µg /L
2 month
Autism symptom severity of children using Childhood Autism rating Scale diagnosis
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
energy intake using proximate analysis of one day major meals
Time Frame: 2 months
proximate analysis of one day major meals will be used to report intake of energy in k cal /100gm
2 months
Ash intake using proximate analysis of one day major meals
Time Frame: 2 months
proximate analysis of one day major meals will be used to report intake of Ash in gm/100gm
2 months
Lipid intake using proximate analysis of one day major meals
Time Frame: 2 months
proximate analysis of one day major meals will be used to report intake of lipid in gm/100gm
2 months
protein intake using proximate analysis of one day major meals
Time Frame: 2 months
proximate analysis of one day major meals will be used to report intake of protein in gm/100gm
2 months
Carbohydrate intake using proximate analysis of one day major meals
Time Frame: 1 week
proximate analysis of one day major meals will be used to report intake of carbohydrate in gm/100gm
1 week
frequency of food group consumption using food frequency questioner
Time Frame: 5 days
percentage of children consuming from each food groups using a food frequency questioner
5 days
dietary diversity score of children using three days food diary
Time Frame: 5 days
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
frequency of food refusal in children using a questioner
Time Frame: 5 days
frequency is scored as never to seldom, mild and sever
5 days
frequency of sensitivity to food
Time Frame: 5 days
frequency is scored as never to seldom, mild and sever
5 days
frequency of gastrointestinal symptoms
Time Frame: 5 days
frequency is scored as never to seldom, mild and sever
5 days
frequency of food allergic reactions
Time Frame: 5 days
frequency is scored as never to seldom, mild and sever
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Feven Yirgu Tamire, Addis Ababa Science and Technology University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2021

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

February 8, 2022

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Due to Ethical issue, sharing data to 3rd party is not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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