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Completed

NCT Number: NCT05515913

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

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.

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Key information

Conditions

Autistic Spectrum Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addis Ababa Science and Technology University

Addis Ababa, 0000, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional status

Other

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

Eating Behavior

Behavioral

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

Urine iodine concentration

Other

the 24 urine iodine concentration of all subjects was under study

Nutrient intake

Other

The nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study

Dietary assessment

Other

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

Other

The autistic severity of ASD diagnosed children was under study as analyzed by childhood autism rating scale diagnosis

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Urine iodine concentration of children

    Time frame: 2 month

    Urine iodine concentration of children in µg /L

  17. 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.

Secondary outcomes

  1. 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. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. frequency of food refusal in children using a questioner

    Time frame: 5 days

    frequency is scored as never to seldom, mild and sever

  9. frequency of sensitivity to food

    Time frame: 5 days

    frequency is scored as never to seldom, mild and sever

  10. frequency of gastrointestinal symptoms

    Time frame: 5 days

    frequency is scored as never to seldom, mild and sever

  11. frequency of food allergic reactions

    Time frame: 5 days

    frequency is scored as never to seldom, mild and sever

Sponsors and collaborators

Lead sponsor

Addis Ababa University

Other

Registry information

Official study 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

Acronym: ASD

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 25, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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