The Effect of High Selenium Functional Food and Selenium Supplement

NCT05218577 | Completed

• 1 other identifier: Neny Triana
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• The change of Developmental level

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

  Baseline and 3 month after the intervention

Secondary Outcomes (4)

• The change of GPx level

  Baseline and 3 month after the intervention

• The change of IL-1 betha level

  Baseline and 3 month after the intervention

• The change of IL-6 level

  Baseline and 3 month after the intervention

• The change of TNF-Alpha level

  Baseline and 3 month after the intervention

Study Arms (3)

HSFF group

EXPERIMENTAL

the group was given high selenium funtion selenium for 3 months

Other: high selenium functional food

Selenium suplemen group

EXPERIMENTAL

the group was given selenium suplemen

Dietary Supplement: selenium supplement

Control group

PLACEBO COMPARATOR

the group was given placebo

Other: Placebo

Interventions

high selenium functional food OTHER

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

Also known as: HSFF

HSFF group

selenium supplement DIETARY_SUPPLEMENT

20 microgram/day selenium suppplement powder.

Selenium suplemen group

Placebo OTHER

the placebo mocaf powder

Control group

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Neny Triana: lead

Study Sites (1)

Neny Triana

Kediri, East Java, 64112, Indonesia

Location

Related Publications (6)

• 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.

  PMID: 26064157 RESULT

• 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.

  PMID: 29763648 RESULT

• 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.

  PMID: 26418822 RESULT

• 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.

  PMID: 24082241 RESULT

• 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.

  PMID: 31629288 RESULT

• 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.

  PMID: 29867038 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Neny Triana

  STIKES Karya Husada Kediri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: participant did'n know what they had got. the investigator did'n know group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: STIKES Karya Husada Kediri

Model Details: The Intervention group were given HSFF and selenium suplemen, and control group was given placebo.

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)