Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001291370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/10/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Plasmalogen supplementation for cognitive function in adolescents with Postural Orthostatic Tachycardia Syndrome (POTS): a pilot study.
Scientific title
Plasmalogen Supplementation and Cognitive Functioning of Adolescents with Postural Orthostatic Tachycardia Syndrome: A Pilot Randomised Controlled Trial.
Additional trial identifiers [1] 318607 0
Nil
Universal Trial Number (UTN)
Trial acronym
HSOP-POTS Pilot Study
Related trial records

Health condition
Health condition(s) studied:
Postural Orthostatic Tachycardia Syndrome (POTS) 343807 0
Condition category
Condition code
Cardiovascular 339944 339944 0 0
Other cardiovascular diseases
Neurological 339945 339945 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants randomised to the intervention arm will receive oral Hokkaido Scallop Oil Plasmalogen (HSOP). Each capsule contains 0.5 mg of scallop-oil-derived plasmalogens. Participants will consume two capsules daily (total plasmalogen dose: 1.0 mg/day) with meals for 90 consecutive days, in addition to their usual standard care for POTS. Usual standard care refers to participants’ existing POTS management, including stable medications and lifestyle measures, which will continue throughout the study.
Intervention code [1] 335511 0
Treatment: Other
Description of the comparator or control
Matched placebo capsules containing the same olive oil and vegetable oil base but without scallop-derived plasmalogens. Placebo capsules match the active capsules in appearance, size, colour, packaging, and dosing schedule. Participants receive two capsules daily for 90 days in addition to usual care.
Control group
Placebo

Outcomes
Primary outcome [1] 347115 0
Recruitment Feasibility (composite outcome)
Timepoint [1] 347115 0
At completion of recruitment.
Primary outcome [2] 347116 0
Study Feasibility (composite outcome)
Timepoint [2] 347116 0
Day 90 (end of intervention period)
Primary outcome [3] 347117 0
Safety and Tolerability of Intervention (composite outcome)
Timepoint [3] 347117 0
Throughout the 90-day intervention period and, for any ongoing adverse events, until resolution or stabilisation as determined by the investigator.
Secondary outcome [1] 468990 0
Change in Stroop Effect (following orthostatic stress)
Timepoint [1] 468990 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [2] 468992 0
Heart rate response to orthostatic stress during the NLT (composite outcome: change in heart rate and mean standing heart rate)
Timepoint [2] 468992 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [3] 468993 0
Change in PROMIS® Paediatric Cognitive Function – Short Form (PCF-SF) scores
Timepoint [3] 468993 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [4] 468994 0
Change in Malmö POTS Symptom Score (MAPS)
Timepoint [4] 468994 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [5] 468996 0
Change in KIDSCREEN quality of life scores
Timepoint [5] 468996 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [6] 468997 0
Change in plasma plasmalogen status (composite outcome: plasma ethanolamine plasmalogen [PlsEtn] and plasma choline plasmalogen [PlsCho])
Timepoint [6] 468997 0
Baseline and Day 90 (end of intervention period)
Secondary outcome [7] 468999 0
Participant experiences of the intervention and study procedures (composite outcome)
Timepoint [7] 468999 0
After the final study visit or upon withdrawal (up to Day 120).

Eligibility
Key inclusion criteria
1 Adolescents aged between 13 and 18 years at the time of providing consent.
2 Current or prior POTS diagnosis by a medical professional based on the international diagnostic criteria as follows:
• HR increase by greater than or equal to 30 bpm within 10 min of standing (greater than or equal to 40 bpm in adolescents or absolute HR greater than 120 bpm in adults)
• No sustained orthostatic hypotension
• Experiencing one or more symptoms of orthostatic intolerance, such as lightheadedness, palpitations, headache, flushing, fatigue, tremulousness, blurred vision, presyncope, or difficulty concentrating for more than 3 months.
3 Functional status based on Karnofsky/Lansky performance scale is 60 and above.
4 Received explanation of the purpose and methods of the study, with written consent (from a parent or legal guardian for young people under 18 years old).
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1 A mental health condition that may impede the patient’s ability to understand the trial procedure.
2 Refusal or unwilling to participate in the trial procedure, even with the parent or legal guardian’s consent.
3 Demonstrating severe uncorrected red-green colour blindness at screening (i.e. correctly identifying less than 12 plates in the Ishihara Colour Blind Test [ICBT]).
4 A heart rate increase of not exceeding 40 bpm within 10 minutes of standing at screening.
5 Showing orthostatic hypotension with a sustained decrease in blood pressure of greater than or equal to 20/10 mmHg after standing at screening.
6 Known or possible pregnancy, desire to become pregnant during the trial period, or currently breastfeeding.
7 Known to have an allergy to, or have previously experienced any adverse reaction to, shellfish, soy, or any ingredient contained in the investigational product.
8 Currently having other underlying chronic conditions, such as anaemia, hyperthyroidism, dehydration, pain, fever, or infections that could cause sinus tachycardia.
9 Currently taking medications that could affect lipid absorption, such as orlistat, ezetimibe, lomitapide, and GLP-1 agonists, to manage pre-existing conditions and cannot stop during the trial period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A co-investigator independent of participant recruitment, enrolment, intervention administration and outcome assessment will maintain the randomisation schedule and allocate the next available Participant Identification Number (PID). Study Coordinators and participants will remain unaware of treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation schedule using block randomisation with a block size of four.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analyses will be primarily descriptive and exploratory. Recruitment, retention, adherence, data completeness and safety outcomes will be summarised descriptively. Secondary outcomes will be summarised using appropriate descriptive statistics and exploratory estimates of change. Formal hypothesis testing is not the aim of this pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2027
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
1/10/2028
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 30359 0
Active Health Clinic Blackburn - Blackburn
Recruitment hospital [2] 30360 0
Active Health Clinic Bendigo - Bendigo
Recruitment postcode(s) [1] 46745 0
3130 - Blackburn
Recruitment postcode(s) [2] 46746 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 323180 0
Commercial sector/Industry
Name [1] 323180 0
Daiwa Pharmaceutical Co., Ltd
Country [1] 323180 0
Japan
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 326149 0
None
Name [1] 326149 0
Address [1] 326149 0
Country [1] 326149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321586 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 321586 0
Ethics committee country [1] 321586 0
Australia
Date submitted for ethics approval [1] 321586 0
31/07/2026
Approval date [1] 321586 0
25/09/2026
Ethics approval number [1] 321586 0
2026/ETH01735
Ethics committee name [2] 321589 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [2] 321589 0
Ethics committee country [2] 321589 0
Australia
Date submitted for ethics approval [2] 321589 0
30/09/2026
Approval date [2] 321589 0
01/10/2026
Ethics approval number [2] 321589 0
H26291

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154170 0
A/Prof Sokcheon Pak
Address 154170 0
School of Dentistry and Medical Sciences, Charles Sturt University, Panorama Avenue, Bathurst NSW 2795, Australia
Country 154170 0
Australia
Phone 154170 0
+61 2 6338 4952
Fax 154170 0
Email 154170 0
[email protected]
Contact person for public queries
Name 154171 0
Sokcheon Pak
Address 154171 0
School of Dentistry and Medical Sciences, Charles Sturt University, Panorama Avenue, Bathurst NSW 2795, Australia
Country 154171 0
Australia
Phone 154171 0
+61 2 6338 4952
Fax 154171 0
Email 154171 0
[email protected]
Contact person for scientific queries
Name 154172 0
Sokcheon Pak
Address 154172 0
School of Dentistry and Medical Sciences, Charles Sturt University, Panorama Avenue, Bathurst NSW 2795, Australia
Country 154172 0
Australia
Phone 154172 0
+61 2 6338 4952
Fax 154172 0
Email 154172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Contact: Assoc Prof Sokcheon Pak
Email: [email protected]
Organisation: Charles Sturt University

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.