- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05515913
Nutritional Status and ASD Severity of Autistic Spectrum Disorder Children in Addis Ababa, Ethiopia; Case Control Study (ASD)
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 Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Addis Ababa, Ethiopia, 0000
- Addis Ababa Science and Technology University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study 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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ASD ( autistic spectrum disorder)
Children already diagnosed with autistic spectrum disorder
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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
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TDC (typically developing children)
Children within the typically development
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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
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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
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Body Mass Index and age will be combined to report Body mass index for age z-score in Kg/m2 for age in months
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1 day
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Height for age z-scores
Time Frame: 1 day
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Height and age will be combined to report height for age z-scores in centimeter for age in months
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1 day
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Weight for age z-scores
Time Frame: 1 day
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weight and age will be combined to report weight for age z-scores in kg for age in months
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1 day
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Zinc intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of zinc in mg/day
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5 days
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Energy intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of energy in kcal/day
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5 days
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Protein intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of protein in gm/day
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5 days
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Lipid intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of lipid in gm/day
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5 days
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Carbohydrate intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of carbohydrate in gm/day
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5 days
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Calcium intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of calcium in mg/day
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5 days
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Iron intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of Iron in mg/day
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5 days
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Thiamine intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of Thiamine in mg/day
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5 days
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Vitamin C intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of vitamin C in mg/day
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5 days
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Vitamin B2 intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of vitamin B2 in mg/day
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5 days
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Niacin intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of niacin in mg/day
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5 days
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Vitamin A intake using three days food diary questioner
Time Frame: 5 days
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Three days food diary questioner will be used to report intake of vitamin A in mg/day
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5 days
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Urine iodine concentration of children
Time Frame: 2 month
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Urine iodine concentration of children in µg /L
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2 month
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Autism symptom severity of children using Childhood Autism rating Scale diagnosis
Time Frame: 2 days
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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.
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2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
energy intake using proximate analysis of one day major meals
Time Frame: 2 months
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proximate analysis of one day major meals will be used to report intake of energy in k cal /100gm
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2 months
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Ash intake using proximate analysis of one day major meals
Time Frame: 2 months
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proximate analysis of one day major meals will be used to report intake of Ash in gm/100gm
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2 months
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Lipid intake using proximate analysis of one day major meals
Time Frame: 2 months
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proximate analysis of one day major meals will be used to report intake of lipid in gm/100gm
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2 months
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protein intake using proximate analysis of one day major meals
Time Frame: 2 months
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proximate analysis of one day major meals will be used to report intake of protein in gm/100gm
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2 months
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Carbohydrate intake using proximate analysis of one day major meals
Time Frame: 1 week
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proximate analysis of one day major meals will be used to report intake of carbohydrate in gm/100gm
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1 week
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frequency of food group consumption using food frequency questioner
Time Frame: 5 days
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percentage of children consuming from each food groups using a food frequency questioner
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5 days
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dietary diversity score of children using three days food diary
Time Frame: 5 days
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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.
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5 days
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frequency of food refusal in children using a questioner
Time Frame: 5 days
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frequency is scored as never to seldom, mild and sever
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5 days
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frequency of sensitivity to food
Time Frame: 5 days
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frequency is scored as never to seldom, mild and sever
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5 days
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frequency of gastrointestinal symptoms
Time Frame: 5 days
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frequency is scored as never to seldom, mild and sever
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5 days
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frequency of food allergic reactions
Time Frame: 5 days
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frequency is scored as never to seldom, mild and sever
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5 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Feven Yirgu Tamire, Addis Ababa Science and Technology University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AASTUASD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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