Wide-spectrum nutritional supplement for Autism Spectrum Disorder

Phase-Based Estimates
1
Effectiveness
2
Safety
Phoenix Children's Hospital, Phoenix, AZ
Autism Spectrum Disorder+2 More
Wide-spectrum nutritional supplement - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Autism Spectrum Disorder

Study Summary

This study is evaluating whether a nutritional supplement may help improve mitochondrial function in children with autism spectrum disorder.

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Eligible Conditions

  • Autism Spectrum Disorder
  • Autistic Disorder
  • Pervasive Development Disorders
  • Child Development Disorders, Pervasive

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Wide-spectrum nutritional supplement will improve 1 primary outcome and 11 secondary outcomes in patients with Autism Spectrum Disorder. Measurement will happen over the course of Screening, Week 12, Week 24.

Week 24
Change in mitochondrial activity in study patients
Change in the Caregiver Strain Questionnaire (CGSQ) score
Change in the Childhood Autism Rating Scale (CARS) score
Change in the Children's Yale-Brown Obsessive Compulsive Scale modified for Autism Spectrum Disorder (CYBOCS-ASD) score
Change in the Clinical Global Impression scale (CGI) score
Change in the Parent-rated Anxiety Scale for ASD (PRAS-ASD) score
Change in the Vineland III Caregiver score
Examine the change in attention to social stimuli
Week 24
Change in the Aberrant Behavior Checklist (ABC) scores
Evaluate intervention effect on cellular regulatory pathways known to be implicated in ASD
Evaluate intervention safety
Examine the change in cognitive ability

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo control
Wide-spectrum nutritional supplement
Placebo group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Wide-spectrum Nutritional Supplement is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Wide-spectrum nutritional supplement
Drug
The Wide-spectrum nutritional supplement used will be a combination of NeuroNeeds: SpectrumNeeds and QNeeds. Weight based dosing will be used. The daily serving size will be divided into two oral daily doses in the form of a powder which can be mixed into liquid or food. Together, there are 34 different dietary supplements in the products. Except for ubiquinol, all of these nutrients are provided in a powder form in SpectrumNeeds. Ubiquinol is provided separately in QNeeds gel capsules. These capsules can be swallowed whole, or cut with scissors and the contents squeezed out and added to SpectrumNeeds just before ingestion.
Placebo control
Other
Participants randomized to receive placebo will take placebo in an oral form divided into powder and a gel capsule in the same manner as treatment. For the second phase of the cross over, participants will be part of the opposite group they were assigned to in Phase I (Placebo or Treatment). Quantities for placebo or treatment will match across phases for each subject, utilizing the same weight based dosing.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12, week 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, week 12, week 24 for reporting.

Who is running the study

Principal Investigator
R. F.
Richard Frye,, MD PhD
Phoenix Children's Hospital

Closest Location

Phoenix Children's Hospital - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Stable educational and therapy plan (one month) with no planned changes in the intensity of treatment for 12 weeks.
English is spoken in the home and at least one parent is able to read, write and speak English.
Stable medication (no changes in past 6 weeks and no planned changes for the study duration.
Electron Transport Chain Complex (I, II, III, IV) or Citrate Synthase Activity which is >= 2.0 Standard Deviation Above or Below Average (outside the normal range)
Weight ≥ 15 kg and ≤ 100kg;
DSM-5 diagnosis of Autism Spectrum Disorder as established by formal clinical assessment which includes a gold-standard tool such as the Autism Diagnostic Observational Schedule.
Current Clinical Global Impression Severity score ≥ 4

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get autism spectrum disorder a year in the United States?

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The approximate annual rate of ASD in the United States is about 1.7 cases per 100,000 children. Although all children with ASD are included in this rate, it is not clear that there is an independent ASD rate and it is possible that there are people with ASD whose symptoms are underdiagnosed as other conditions. Thus the ASD rate is underestimated. This rate will probably remain stable or increase over the next 20 yr. In this article, we address current epidemiologic estimates of ASD and show, in various ways, how much more data are needed.

Unverified Answer

What are the signs of autism spectrum disorder?

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Findings indicate that autism and autism spectrum disorder share common signs, most of which are cognitive in nature. This association suggests that autism and ASD may be related phenomenologically and clinically.

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What are common treatments for autism spectrum disorder?

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A wide variety of treatments are used to treat autism and ASD, including medication and therapies applied directly to the child (e.g., speech therapy), or applied to family members (e.g., behavior therapy). More than one of these therapies is often used in combination to promote growth and quality of life in children with autism.

Unverified Answer

Can autism spectrum disorder be cured?

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ASD manifests differently in different patients depending whether the clinical presentation involves social deficits or behavioral difficulties. The behavioral difficulties of ASD resolve when the patient receives appropriate treatment.

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What is autism spectrum disorder?

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ASD is a diverse family of illnesses characterized by the presence of symptoms in at least two separate areas, each suggestive of a different underlying cause; that is, it might be best described as a syndrome (an assembly of two or more symptoms).

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What causes autism spectrum disorder?

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There are other contributing factors in ASD besides the disorder's etiology that have to be considered. Current therapies for ASD have shown to mostly have a therapeutic effect, but, there is not yet any cure for autism. A combination of treatment such as behavioral, social, and communication intervention can also be used to improve ASD patients’ functioning.

Unverified Answer

Has wide-spectrum nutritional supplement proven to be more effective than a placebo?

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Children receiving WSS demonstrated a reduction in ASD symptoms in the short term compared to the placebo group, and similar improvements in the long term compared to the standard nutrition programme.

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Does wide-spectrum nutritional supplement improve quality of life for those with autism spectrum disorder?

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We assessed the effect of a broad spectrum dietary supplement of 2 g/day of L-cysteine on 6-mo QOL among this small sample at risk for ASD. While limited by small sample size, this finding suggests that the use of this supplement may be useful in patients at risk for ASD. (Jobs Medical Nutrition. 2016;13(1)(Suppl 1).

Unverified Answer

What is wide-spectrum nutritional supplement?

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Wide-spectrum nutritional supplements, mainly composed of minerals from seawater, are safe and may contribute with many beneficial effects to the autistic child's nutritional status, but further studies are needed.

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What is the primary cause of autism spectrum disorder?

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While other causes of autism are known, our results suggest that epigenetic alteration may play a pivotal role in the etiology of ASD. Furthermore, epigenetics is likely to be one mechanism explaining the sex differences in ASD pathogenesis. The epigenetic alterations can be induced by environmental factors, such as the maternal environment or the environmental factors that alter maternal DNA methylation profiles.

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What are the common side effects of wide-spectrum nutritional supplement?

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There are many common side effects of all supplements and some possible side effects of specific supplements. People should read the package insert of any supplement to know what the common side effects are, and not to stop taking any particular supplement.

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What is the latest research for autism spectrum disorder?

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This article presents the most frequently cited studies for autism spectrum disorder published in the 21st century; they provide a benchmark for evaluating autism spectrum disorder research. There has been continual development of new scientific research on this topic. This article was intended to reflect the most relevant studies published after 2008. This article includes all autism spectrum disorder research published since 2008.

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