Fatty Acid Oxidation DisorderNCT04400422
Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders
A study testing Lipano formula in people with Fatty Acid Oxidation Disorder, run by Dr. Schär AG / SPA at 1 site in Russia.
Trial summary
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Fatty Acid Oxidation Disorder
- What is being tested?
- Lipano formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jun 2018to 20 Sep 2018
- 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 Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
- Patients from birth to 18 months
- Written informed consent obtained from patient or parental caregiver
Who cannot join
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study
- Patients over 18 months of age
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian Children's Hospital Center for Orphan Diseases
Moscow, 117513
About this study
Official title: Experience of Using Lipano in Children With LCHAD (Long Chain Fatty Acid Oxidation Disorder)
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study
- Conditions
- Fatty Acid Oxidation Disorder
- Being tested
- Lipano formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipano formulaDietary supplement
Subjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD
| Study group | Role | What they receive |
|---|---|---|
| Lipano MCT formula | Experimental | Kanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance Receives: Dietary Supplement: Lipano formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance: questionnaire
Daily questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Measured: 90 days
Product compliance
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Measured: 90 days
Product palatability
Questionnaire data captured to evaluate taste
Measured: 90 days
Product acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Measured: 90 days
Secondary outcomes (4)
Biochemistry stability - creatine kinase
creatine kinase will be monitored
Measured: 90 days
Biochemistry stability - liver enzymes
liver enzymes will be monitored
Measured: 90 days
Anthropometry 1
weight in g monitored to check growth
Measured: 90 days
Anthropometry 2
height in cm monitored to check growth
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start20 Jun 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Acid Oxidation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Schär AG / SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400422
- Sponsor's protocol ID
- Lipano 1 - Case
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Using Lipano in Children With LCHAD (Long Chain Fatty Acid Oxidation Disorder)
- ClinicalTrials.gov ID
- NCT04400422
- Acronym / sponsor ID
- Lipano 1 - Case
- Conditions
- Fatty Acid Oxidation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dr. Schär AG / SPAIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipano MCT formula | Experimental | Dietary Supplement: Lipano formulaKanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
- Patients from birth to 18 months
- Written informed consent obtained from patient or parental caregiver
Key exclusion criteria (5 listed)
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study
- Patients over 18 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipano formulaSubjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD | Dietary supplement | Lipano MCT formula |
Primary outcome
Gastrointestinal tolerance: questionnaire
Time frame: 90 days
Daily questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Product compliance
Time frame: 90 days
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability
Time frame: 90 days
Questionnaire data captured to evaluate taste
Product acceptability
Time frame: 90 days
Brief tick-box questionnaire on overall liking and acceptability of product
4 secondary outcomes
Biochemistry stability - creatine kinase
Time frame: 90 days
Biochemistry stability - liver enzymes
Time frame: 90 days
Anthropometry 1
Time frame: 90 days
Anthropometry 2
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No. This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipano formula in people with Fatty Acid Oxidation Disorder, run by Dr. Schär AG / SPA at 1 site in Russia.
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 5 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 22 May 2020. 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 Russia. 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. 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?
Gastrointestinal tolerance: questionnaire (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.