Autistic Spectrum DisorderASDNCT05515913
Nutritional Status and ASD Severity of Autistic Spectrum Disorder Children in Addis Ababa, Ethiopia; Case Control Study
An observational study of Autistic Spectrum Disorder, run by Addis Ababa University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Spectrum Disorder
- What is being tested?
- Nutritional status, Eating behavior and Urine iodine concentration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteEthiopia
- Study dates
- 14 Aug 2021to 8 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Children already diagnosed with ASD
- school aged children (4-18 years old)
Who cannot join
- children with chronic illnesses ( such as cancer..)
- children taking heavy medications that may affect diet and nutrition
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Addis Ababa Science and Technology University
Addis Ababa, 0000
About this 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
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.
Read the 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.
- Conditions
- Autistic Spectrum Disorder
- Being tested
- Nutritional status, Eating behavior, Urine iodine concentration, Nutrient intake, Dietary assessment
- Keywords
- Autistic spectrum disorder (ASD), Typically developing children (TDC), Nutritional status, Nutrient intake, Urine Iodine, Autistic severity
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional statusOther
Nutritional status of children as analyzed by anthropometric indices was under study
Eating behaviorBehavioural
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 concentrationOther
the 24 urine iodine concentration of all subjects was under study
Nutrient intakeOther
The nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study
Dietary assessmentOther
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 scaleOther
The autistic severity of ASD diagnosed children was under study as analyzed by childhood autism rating scale diagnosis
| Study group | Role | What they receive |
|---|---|---|
| ASD ( autistic spectrum disorder) | Children already diagnosed with autistic spectrum disorder Receives: Other: Nutritional status; Behavioral: Eating behavior; Other: Urine iodine concentration; Other: Nutrient intake; Other: Dietary assessment; Other: Childhood autism rating scale | |
| TDC (typically developing children) | Children within the typically development Receives: Other: Nutritional status; Other: Urine iodine concentration; Other: Nutrient intake; Other: Dietary assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Height for age z-scores
Height and age will be combined to report height for age z-scores in centimeter for age in months
Measured: 1 day
Weight for age z-scores
weight and age will be combined to report weight for age z-scores in kg for age in months
Measured: 1 day
Zinc intake using three days food diary questioner
Three days food diary questioner will be used to report intake of zinc in mg/day
Measured: 5 days
Energy intake using three days food diary questioner
Three days food diary questioner will be used to report intake of energy in kcal/day
Measured: 5 days
Protein intake using three days food diary questioner
Three days food diary questioner will be used to report intake of protein in gm/day
Measured: 5 days
Lipid intake using three days food diary questioner
Three days food diary questioner will be used to report intake of lipid in gm/day
Measured: 5 days
Carbohydrate intake using three days food diary questioner
Three days food diary questioner will be used to report intake of carbohydrate in gm/day
Measured: 5 days
Calcium intake using three days food diary questioner
Three days food diary questioner will be used to report intake of calcium in mg/day
Measured: 5 days
Iron intake using three days food diary questioner
Three days food diary questioner will be used to report intake of Iron in mg/day
Measured: 5 days
Thiamine intake using three days food diary questioner
Three days food diary questioner will be used to report intake of Thiamine in mg/day
Measured: 5 days
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
Measured: 5 days
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
Measured: 5 days
Niacin intake using three days food diary questioner
Three days food diary questioner will be used to report intake of niacin in mg/day
Measured: 5 days
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
Measured: 5 days
Urine iodine concentration of children
Urine iodine concentration of children in µg /L
Measured: 2 month
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.
Measured: 2 days
Secondary outcomes (11)
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 1 week
frequency of food group consumption using food frequency questioner
percentage of children consuming from each food groups using a food frequency questioner
Measured: 5 days
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.
Measured: 5 days
frequency of food refusal in children using a questioner
frequency is scored as never to seldom, mild and sever
Measured: 5 days
frequency of sensitivity to food
frequency is scored as never to seldom, mild and sever
Measured: 5 days
frequency of gastrointestinal symptoms
frequency is scored as never to seldom, mild and sever
Measured: 5 days
frequency of food allergic reactions
frequency is scored as never to seldom, mild and sever
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start14 Aug 2021
- Primary completion23 Nov 2021
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feven yirgu Tamire, Addis Ababa University
- Investigators
- Feven Yirgu Tamire, Principal investigator, Addis Ababa Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515913
- Sponsor's protocol ID
- AASTUASD
- Acronym
- ASD
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to Ethical issue, sharing data to 3rd party is not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05515913
- Acronym / sponsor ID
- ASD / AASTUASD
- Conditions
- Autistic Spectrum Disorder
- Keywords
- Autistic spectrum disorder (ASD), Typically developing children (TDC), Nutritional status, Nutrient intake, Urine Iodine, Autistic severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD ( autistic spectrum disorder) | – | Other: Nutritional status, Behavioral: Eating behavior, Other: Urine iodine concentration, Other: Nutrient intake, Other: Dietary assessment, Other: Childhood autism rating scaleChildren already diagnosed with autistic spectrum disorder |
| TDC (typically developing children) | – | Other: Nutritional status, Other: Urine iodine concentration, Other: Nutrient intake, Other: Dietary assessmentChildren within the typically development |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Children already diagnosed with ASD
- school aged children (4-18 years old)
Key exclusion criteria (2 listed)
- children with chronic illnesses ( such as cancer..)
- children taking heavy medications that may affect diet and nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional statusNutritional status of children as analyzed by anthropometric indices was under study | Other | ASD ( autistic spectrum disorder), TDC (typically developing children) |
| Eating behaviorThe 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 | Behavioural | ASD ( autistic spectrum disorder) |
| Urine iodine concentrationthe 24 urine iodine concentration of all subjects was under study | Other | ASD ( autistic spectrum disorder), TDC (typically developing children) |
| Nutrient intakeThe nutrient intake as analyzed by three days food diary and major meal proximate analysis of subjects was under study | Other | ASD ( autistic spectrum disorder), TDC (typically developing children) |
| Dietary assessmentThe food frequency and dietary diversity of all subjects as analyzed by food frequency questioner, dietary diversity score and food variety score was under study | Other | ASD ( autistic spectrum disorder), TDC (typically developing children) |
| Childhood autism rating scaleThe autistic severity of ASD diagnosed children was under study as analyzed by childhood autism rating scale diagnosis | Other | ASD ( autistic spectrum disorder) |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Urine iodine concentration of children
Time frame: 2 month
Urine iodine concentration of children in µg /L
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.
11 secondary outcomes
energy intake using proximate analysis of one day major meals
Time frame: 2 months
Ash intake using proximate analysis of one day major meals
Time frame: 2 months
Lipid intake using proximate analysis of one day major meals
Time frame: 2 months
protein intake using proximate analysis of one day major meals
Time frame: 2 months
Carbohydrate intake using proximate analysis of one day major meals
Time frame: 1 week
frequency of food group consumption using food frequency questioner
Time frame: 5 days
dietary diversity score of children using three days food diary
Time frame: 5 days
frequency of food refusal in children using a questioner
Time frame: 5 days
frequency of sensitivity to food
Time frame: 5 days
frequency of gastrointestinal symptoms
Time frame: 5 days
frequency of food allergic reactions
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Undecided. Due to Ethical issue, sharing data to 3rd party is not decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feven Yirgu Tamire principal investigator
Addis Ababa Science and Technology University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Spectrum Disorder, run by Addis Ababa University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index for age z-scores (time frame: 1 day). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.