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Autism Spectrum DisorderNCT05218577

The Effect of High Selenium Functional Food and Selenium Supplement

A study testing high selenium functional food and selenium supplement in people with Autism Spectrum Disorder, run by Neny Triana at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of ASD is increasing every year. Report data from the Center for Diseases Control and Prevention (CDC) 1: 68 in 2016 means that out of 68 children, there is 1 child with ASD, while in 2017 it increased by 1: 36, meaning that out of 36 children there is 1 child with ASD1. Read more about this study

Who is it for?
Ages 2 months to 6 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
high selenium functional food and selenium supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteIndonesia
Study dates
1 Jan 2021to 24 Dec 2021
Phase
Interventional
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 2 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children diagnosed with ASD by a pediatrician, based on DSM-5
  • ASD children aged 2-6 years.
  • ASD children receiving medical and non-medical therapy.

Who cannot join

  • ASD children who were not at the study site.
  • Children with ASD are accompanied by severe congenital abnormalities.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Neny Triana

    Kediri, East Java, 64112

Other trials in Indonesia

About this study

Official title: The Effect of High Selenium Functional Food and Selenium Supplement on Developmental Level in Autism Spectrum Disorder

The prevalence of ASD is increasing every year. Report data from the Center for Diseases Control and Prevention (CDC) 1: 68 in 2016 means that out of 68 children, there is 1 child with ASD, while in 2017 it increased by 1: 36, meaning that out of 36 children there is 1 child with ASD1. ASD in men is 4 times greater than in women. This study used Randomized Controlled Clinical Trials (RCT), double blind, 65 research subjects randomized to provide intervention for 3 months in group 1 (n = 22) processed beef liver high in selenium, group 2 (n = 22) supplemented with selenium, group 2 (n = 22) supplemented with selenium, group 1 (n = 22) 3 (n=21) control group. Outcome of ATEC score measurement in the three groups. Major hypothesis There is a difference in the comparison of giving high selenium functional food (HSFF) with selenium supplements to decreasing ATEC scores in Autism Spectrum Disorder (ASD) children, increasing levels of the enzyme glutathione peroxidase (GPx), and decreasing IL-β, IL-6 and TNF-α . Minor Hypothesis. a. There was a decrease in the ATEC score of ASD children in the intervention group of processed beef liver high in selenium, selenium supplementation compared to the control group b. The difference in the increase in GPx enzyme levels in the intervention group processed beef liver high in selenium, selenium supplementation compared to the control group in ASD children. c. Differences in decreased levels of IL-1β in the intervention group processed beef liver high in selenium, selenium supplementation compared to the control group with ASD.d. Differences in decreased levels of IL-6 in the intervention group processed high-selenium beef liver, selenium supplementation compared to the control group with ASD children. e. Differences in decreased levels of TNF- in the intervention group processed beef liver high in selenium, selenium supplementation compared to the control group with ASD children. Participants were randomized into three groups: Intervention group 1 high selenium functional food (n=22), Intervention 2 selenium supplement and group 3 control (n=21).

Read the detailed description

Introduction:

Autism Spectrum Disorder (ASD) is a developmental disorder, which is characterized by two symptoms, namely, barriers to communication/social interaction and restrictive/repetitive behavior. Knowing children with ASD, parents reported their children at the age of 18 months with verbal and non-verbal speech delays compared to children their age. To find out as early as possible children with ASD, it is necessary to be screened at the age of 18 and 24 months, before a diagnosis of ASD is made based on the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5), this is to conduct early intensive intervention in improving the disorder. its development. The prevalence of ASD is increasing every year. Report data from the Center for Diseases Control and Prevention (CDC) 1: 68 in 2016 means that out of 68 children, there is 1 child with ASD, while in 2017 it increased by 1: 36, meaning that out of 36 children there is 1 child with ASD1. ASD in men is 4 times greater than in women.

The causes of ASD are non-genetic and genetic. Non genetic include, neuroinflammation and neuroimmunity, digestive disorders, neuropathology, heavy metal poisoning. Inflammation of the innervation of children with ASD causes the production of pro-inflammatory cytokines to increase. Cytokines that play a role in ASD innervation are IL-1 , IL-6 and TNF-α. These cytokines can cross the blood-brain barrier, thereby influencing behavior in ASD. Children with ASD also experience bacterial abnormalities in their stools. Based on the results of the study of bacterial cultures in the feces of children with ASD, significant Bifidobacterium, Escherichia coli, Lactobacillus, and Enterococcus bacteria were found. This increase in faecal flora indicates intestinal inflammation in ASD children, this causes the blood brain barrier to be disrupted, because the intestinal function that provides nutrients to neurons is not optimal, thus affecting the work of the nervous system as a trigger for neuroinflammation. Heavy metal poisoning, in ASD there was an increase in the concentration of Hg in the hair, and there was a significant relationship between lead content in ASD hair and the development of verbal communication (p= 0.020). Genetic factors, ± 15% ASD It is estimated that 37%-90% of siblings with ASD twins will be at risk of developing ASD in their siblings.

Interprofessional ASD handling involves inter-professional collaboration pediatricians, psychologists, nurses, medical rehabilitation, and nutritionists working as a team to help families with ASD children. Early treatment before the age of 3 years, highly recommended. The goal of ASD treatment is to maximize the child's independence and quality of life by minimizing the symptoms of ASD development. Treatment with Complementary and Alternative Medicine (CAM) is used for the prevention, cure and promotion of ASD. CAM is divided into biological therapies including casein free, gluten free, sugar free (CFGFSF) dietary interventions, supplements, and non-biological, including social therapy, hearing integration training, sensory integration therapy, drama therapy, dance therapy, acupuncture, massage therapy, yoga and animal therapy.

One of the treatments for CAM with biologic therapy in ASD is selenium supplementation, where selenium is essential for specific, non-specific, and antioxidant immune responses. Selenium given to ASD, is a selenoprotein element as an essential component of the enzyme glutathione peroxidase (GPx). GPx acts to reduce hydrogen peroxide (H₂O₂) to water (H2O), improve neuronal degeneration and release reactive oxygen species (ROS) due to oxidative stress. Selenium as an antioxidant compound, is a compound that works by donating one electron or giving electrons (electron donors) to compounds that are oxidant, so that the activity of these oxidant compounds can be inhibited.

Formulation of the problem:

Can administration of high selenium functional food (HSFF) reduce ATEC scores in developing ASD children, increase GPx, decrease IL-1 , IL-6, and TNF- compared to selenium supplements

Research purposes:

Proving the comparison of giving high selenium functional food (HSFF) with supplemental selenium (SS) on the clinical development of ASD children, can decreased ATEC score, increased GPx, decreased IL-1 , IL-6, and TNF-α.

Research Hypothesis:

There is a difference in the comparison of giving high selenium functional food (HSFF) with selenium supplements to decreasing ATEC scores in children with Autism Spectrum Disorder (ASD), increasing levels of the enzyme glutathione peroxidase (GPx), and decreasing IL-β, IL-6 and TNF-α.

Benefits of research:

Provides academic benefits in improving pediatric nursing knowledge, the immune system IL-1β, IL-6, and TNF-α and GPx antioxidants related to high-slenium beef liver preparations and selenium supplements in the development of ASD children.

Research methods:

A true experimental study with a randomized controlled group pre-post test design. The research subjects were ASD boys and girls (n=65), divided into 3 groups, 22 subjects were given processed beef liver high in selenium, 22 subjects were supplemented with selenium, 21 subjects were controls. The characteristics of the research subjects included age, gender, first diagnosed with ASD, knowledge of diet and doctor's therapy. Each group was assessed for development by ATEC scores, levels of GPx, IL-1β, IL-6 and TNF-α before and after the intervention. The intervention group 1 was given processed beef liver with high selenium, the intervention group 2 was given selenium supplementation and group 3 as a control was given mocaf flour for 3 months.

The normality test of the data distribution was carried out by Kolmogorov-Smirnov, to determine the results before and after the intervention with the paired, unpaired t-parametric test and One Way Anova and the non-parametric Chi-Square test, Kruskal Wallis.

Being tested
high selenium functional food, selenium supplement, Placebo
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.

  • high selenium functional foodOther

    Also called HSFF

    HSFF was made from the liver of the cow, that participant could eat HSFF direcly.

  • selenium supplementDietary supplement

    20 microgram/day selenium suppplement powder.

  • PlaceboOther

    the placebo mocaf powder

Study groups in NCT05218577
Study groupRoleWhat they receive
HSFF groupExperimentalthe group was given high selenium funtion selenium for 3 months
Receives: Other: high selenium functional food
Selenium suplemen groupExperimentalthe group was given selenium suplemen
Receives: Dietary Supplement: selenium supplement
Control groupPlacebo comparatorthe group was given placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of Developmental level

    Developmental level was measured by Autism Treatment Evaluation Cheecklist (ATEC)

    Measured: Baseline and 3 month after the intervention

Secondary outcomes (4)
  1. The change of GPx level

    Gluthation peroxidase is antioxidant that measured in the laboratory using elisa method

    Measured: Baseline and 3 month after the intervention

  2. The change of IL-1 betha level

    IL-1 Betha is pro inflamation that measured in the laboratory using elisa method

    Measured: Baseline and 3 month after the intervention

  3. The change of IL-6 level

    IL-6 is pro inflamation that measured in the laboratory using elisa method

    Measured: Baseline and 3 month after the intervention

  4. The change of TNF-Alpha level

    TNF-Alpha is pro inflamation that measured in the laboratory using elisa method

    Measured: Baseline and 3 month after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start1 Jan 2021
  3. Primary completion24 Dec 2021
  4. Study completion24 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Intervention group were given HSFF and selenium suplemen, and control group was given placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218577
Sponsor's protocol ID
Neny Triana
Status last verified
Jan 2022
First submitted
30 Jan 2022
Last updated
1 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I did'd have a plan share the date

Publications

  • Brondino N, Fusar-Poli L, Rocchetti M, Provenzani U, Barale F, Politi P. Complementary and Alternative Therapies for Autism Spectrum Disorder. Evid Based Complement Alternat Med. 2015;2015:258589. doi: 10.1155/2015/258589. Epub 2015 May 7.

    PubMed 26064157
  • Sharma SR, Gonda X, Tarazi FI. Autism Spectrum Disorder: Classification, diagnosis and therapy. Pharmacol Ther. 2018 Oct;190:91-104. doi: 10.1016/j.pharmthera.2018.05.007. Epub 2018 May 12.

    PubMed 29763648
  • Lange KW, Hauser J, Reissmann A. Gluten-free and casein-free diets in the therapy of autism. Curr Opin Clin Nutr Metab Care. 2015 Nov;18(6):572-5. doi: 10.1097/MCO.0000000000000228.

    PubMed 26418822
  • Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.

    PubMed 24082241
  • Kordulewska NK, Kostyra E, Piskorz-Ogorek K, Moszynska M, Cieslinska A, Fiedorowicz E, Jarmolowska B. Serum cytokine levels in children with spectrum autism disorder: Differences in pro- and anti-inflammatory balance. J Neuroimmunol. 2019 Dec 15;337:577066. doi: 10.1016/j.jneuroim.2019.577066. Epub 2019 Sep 15.

    PubMed 31629288
  • Siniscalco D, Schultz S, Brigida AL, Antonucci N. Inflammation and Neuro-Immune Dysregulations in Autism Spectrum Disorders. Pharmaceuticals (Basel). 2018 Jun 4;11(2):56. doi: 10.3390/ph11020056.

    PubMed 29867038

Questions about this trial

What is this clinical trial studying?

A study testing high selenium functional food and selenium supplement in people with Autism Spectrum Disorder, run by Neny Triana at 1 site in Indonesia.

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 3 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 1 Feb 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?

The change of Developmental level (time frame: Baseline and 3 month after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218577, which also lists 6 linked publications.

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 1 Feb 2022.

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