NCT05515913

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 19, 2022

Last Update Submit

August 23, 2022

Conditions

Autistic Spectrum Disorder

Keywords

Autistic spectrum disorder (ASD)Typically developing children (TDC)Nutritional statusNutrient intakeUrine IodineAutistic severity

Outcome Measures

Primary Outcomes (17)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Urine iodine concentration of children

    Urine iodine concentration of children in µg /L

    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.

    2 days

Secondary Outcomes (11)

  • energy intake using proximate analysis of one day major meals

    2 months

  • Ash intake using proximate analysis of one day major meals

    2 months

  • Lipid intake using proximate analysis of one day major meals

    2 months

  • protein intake using proximate analysis of one day major meals

    2 months

  • Carbohydrate intake using proximate analysis of one day major meals

    1 week

  • +6 more secondary outcomes

Study Arms (2)

ASD ( autistic spectrum disorder)

Children already diagnosed with autistic spectrum disorder

Other: Nutritional statusBehavioral: Eating behaviorOther: Urine iodine concentrationOther: Nutrient intakeOther: Dietary assessmentOther: Childhood autism rating scale

TDC (typically developing children)

Children within the typically development

Other: Nutritional statusOther: Urine iodine concentrationOther: Nutrient intakeOther: Dietary assessment

Interventions

Nutritional statusOTHER

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

ASD ( autistic spectrum disorder)TDC (typically developing children)
Eating behaviorBEHAVIORAL

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

ASD ( autistic spectrum disorder)
Urine iodine concentrationOTHER

the 24 urine iodine concentration of all subjects was under study

ASD ( autistic spectrum disorder)TDC (typically developing children)
Nutrient intakeOTHER

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

ASD ( autistic spectrum disorder)TDC (typically developing children)
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

ASD ( autistic spectrum disorder)TDC (typically developing children)
Childhood autism rating scaleOTHER

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

ASD ( autistic spectrum disorder)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Children already diagnosed with ASD
  • school aged children (4-18 years old)

You may not qualify if:

  • children with chronic illnesses ( such as cancer..)
  • children taking heavy medications that may affect diet and nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addis Ababa Science and Technology University

Addis Ababa, 0000, Ethiopia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine analysis

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Nutritional StatusEatingNutrition Assessment

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsDigestive System Physiological PhenomenaDigestive System and Oral Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Feven Yirgu Tamire

    Addis Ababa Science and Technology University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 25, 2022

Study Start

August 14, 2021

Primary Completion

November 23, 2021

Study Completion

February 8, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

ET(1)