Essential Fatty Acid Deficiency (EFAD)Phase 4NCT04555044

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)

A Phase 4 study testing Clinolipid and Intralipid in people with Essential Fatty Acid Deficiency (EFAD), run by Baxter Healthcare Corporation at 9 sites in United States.

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

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Read more about this study

Who is it for?: Ages 0 to 17 years
Conditions the study is for: Essential Fatty Acid Deficiency (EFAD)
What is being tested?: Clinolipid and Intralipid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 9 sitesUnited States
Study dates: 22 Jan 2021to 16 Nov 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
Patients and/or their legal representative accept adherence to protocol requirements
Patients who are expected to require parenteral nutrition (PN)for at least 7 days
Premature infants (born at 24 to <37 weeks of gestation with a birth weight ≥750g) require at least 80% of targeted energy requirements by PN at study entry (up to 1 month CA); full term infants and children require at least 70% of targeted energy requirements by PN at study entry

Who cannot join

Patients who are not expected to survive hospitalization or with a severe critical unresponsive illness at time of initiation with foreseeable intercurrent events that could jeopardize the patient's participation in the study, as judged by the Investigator (e.g., unresponsive shock, sepsis, renal failure requiring dialysis, severe unresponsive metabolic acidosis, and/or severe unresponsive metabolic disorders);
Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container or who have a history of an adverse event due to ILE;
Patients with liver disease including cholestasis;
Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL);
Patients who are unable to tolerate the necessary laboratory monitoring;
Patients who are enrolled in another clinical trial involving an investigational agent;

Show all 13Show fewer

Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;
Premature infants born <24 weeks of gestation and patients ≥18 years;
Premature infants with a birth weight <750 g;
Patient requires or is expected to require propofol for sedation;
Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis <2 months prior and/or symptoms have not resolved.
Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery
Female patients who are pregnant. Note: All female patients ≥12 years of age must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening. For female patients <12 years of age, a urine hCG test at screening will be performed at the discretion of the investigator based on childbearing potential.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Baxter Investigational Site
Boston, Massachusetts, 09111
Baxter Investigational Site
Greenville, North Carolina, 27834
Baxter Investigational Site
Jackson, Mississippi, 39216
Baxter Investigational Site
Memphis, Tennessee, 38163
Baxter Investigational Site
Mobile, Alabama, 36604
Baxter Investigational Site
New Haven, Connecticut, 06520
Baxter Investigational Site
Orlando, Florida, 32803
Baxter Investigational Site
Provo, Utah, 84604
Baxter Investigational Site
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion (Part A)

Conditions: Essential Fatty Acid Deficiency (EFAD)
Being tested: Clinolipid, Intralipid
Keywords: Essential Fatty Acids (EFA), Parenteral Nutrition, Clinolipid/Clinoleic, Parenteral Nutrition Associated Cholestasis (PNAC), Parenteral Nutrition Associated Liver Disease (PNALD), Intestinal Failure Associated Liver Disease (IFALD), Phytosterols, Intralipid, Infants/Preterm Infants, FADS1 and FADS2, Short Bowel Syndrome, Cancer Nutrition, Olive Oil Emulsion, Soybean Oil Emulsion
Medical subject headings: Hyperphagia, Pena Shokeir syndrome, type 1, Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClinolipidDrug
Lipid injectable emulsion, USP 20%
IntralipidDrug
Standard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)

Study groups in NCT04555044
Study group	Role	What they receive
Clinolipid	Experimental	Dosing based on American Academy of Pediatrics (AAP), American Academy Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)/ European Society for Parenteral and Enteral Nutrition (ESPEN)/ European Society of Paediatric Research (ESPR)/ Chinese Society for Parenteral and Enteral Nutrition (CSPEN) guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours. Receives: Drug: Clinolipid
Intralipid	Active comparator	Dosing based on AAP, ASPEN, ESPGHAN/ESPEN/ESPR/CSPEN guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours. Receives: Drug: Intralipid

What is being measured

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

Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid [mead acid] to 5,8,11,14 eicosatetraenoic acid [arachidonic acid, [ARA] ratio
Measured: Up to Day 90

Secondary outcomes (21)

Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)
Defined by direct bilirubin ≥2 mg/dL in patients receiving with intravenous lipid emulsion (ILE).
Measured: Up to Day 90
Alkaline Phosphatase (ALP)
Plasma liver function test
Measured: Up to Day 90
Aspartate Aminotransferase (AST)
Plasma liver function test
Measured: Up to Day 90
Alanine Aminotransferase (ALT)
Plasma liver function test
Measured: Up to Day 90
Gamma-Glutamyl Transferase (GGT)
Plasma liver function test
Measured: Up to Day 90
Total Bilirubin
Plasma liver function test
Measured: Up to Day 90
Direct Bilirubin
Plasma liver function test
Measured: Up to Day 90
Stigmasterol Blood Level
Phytosterol species
Measured: Up to Day 90
Campesterol Blood Level
Phytosterol species
Measured: Up to Day 90
Sitosterol Blood Level
Phytosterol species.
Measured: Up to day 90
Cholesterol Blood Level
Measured: Up to Day 90
Squalene Blood Level
Measured: Up to Day 90
Calories Nutritional Intake
Measured: Up to Day 90
Protein Nutritional Intake
Measured: Up to Day 90
Lipid Nutritional Intake
Measured: Up to Day 90
Carbohydrates Nutritional Intake
Measured: Up to Day 90
Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline
Change in length/height from baseline (mm/week in all) = [Length (mm) on Day X - Length (mm) at baseline] / [X/7] Change in head circumference from baseline (mm/week in infants <1 year) = [Head circumference (mm) on Day X - Head circumference (mm) at baseline] / [X/7]
Measured: Up to Day 90
Body Weight
Change in Weight. from baseline (g/kg/day) to EOT for infants < 1 year of Age
Measured: Up to day 90
Body Weight
Change in weight from baseline to end of treatment (EOT) for those > 1 year of age (g/day)
Measured: Upto Day 90
Number of Adverse Events of Special Interest
Measured: Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred)
Number of Participants With Neonatal Morbidities
Neonatal Morbidities are presented for premature infants born < 37 weeks of gestation up to 1 month corrected age. Patients may have more than 1 neonatal morbidity.
Measured: Up to Day 90

Timeline

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

22 Jan 202116 Nov 2022

First posted18 Sep 2020
Study start22 Jan 2021
Primary completion16 Oct 2022
Study completion16 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Essential Fatty Acid Deficiency (EFAD)Studies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04555044
Sponsor's protocol ID: 6344-001A
Status last verified: Dec 2023
First submitted: 8 Sep 2020
Last updated: 27 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Blanco C, Chang W, Bhatt AJ, Gerday E, Talati AJ, Dereddy N, Singh R, Ryan E, Senterre T. Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):314-323. doi: 10.1002/jpn3.70072. Epub 2025 May 25.
PubMed 40415417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
RecruitingObservational study
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency

All Essential Fatty Acid Deficiency (EFAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion (Part A)
ClinicalTrials.gov ID: NCT04555044
Acronym / sponsor ID: 6344-001A
Conditions: Essential Fatty Acid Deficiency (EFAD)
Keywords: Essential Fatty Acids (EFA), Parenteral Nutrition, Clinolipid/Clinoleic, Parenteral Nutrition Associated Cholestasis (PNAC), Parenteral Nutrition Associated Liver Disease (PNALD), Intestinal Failure Associated Liver Disease (IFALD), Phytosterols, Intralipid
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Study start: 22 Jan 2021 (actual)
Primary completion: 16 Oct 2022 (actual)
Study completion: 16 Nov 2022 (actual)
First posted: 18 Sep 2020 (actual)
Results: Posted 27 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Clinolipid	Experimental	Drug: ClinolipidDosing based on American Academy of Pediatrics (AAP), American Academy Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)/ European Society for Parenteral and Enteral Nutrition (ESPEN)/ European Society of Paediatric Research (ESPR)/ Chinese Society for Parenteral and Enteral Nutrition (CSPEN) guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.
Intralipid	Active comparator	Drug: IntralipidDosing based on AAP, ASPEN, ESPGHAN/ESPEN/ESPR/CSPEN guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.

Who may qualify

Ages: 0 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
Patients and/or their legal representative accept adherence to protocol requirements
Patients who are expected to require parenteral nutrition (PN)for at least 7 days
Premature infants (born at 24 to <37 weeks of gestation with a birth weight ≥750g) require at least 80% of targeted energy requirements by PN at study entry (up to 1 month CA); full term infants and children require at least 70% of targeted energy requirements by PN at study entry

Key exclusion criteria (13 listed)

Patients who are not expected to survive hospitalization or with a severe critical unresponsive illness at time of initiation with foreseeable intercurrent events that could jeopardize the patient's participation in the study, as judged by the Investigator (e.g., unresponsive shock, sepsis, renal failure requiring dialysis, severe unresponsive metabolic acidosis, and/or severe unresponsive metabolic disorders);
Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container or who have a history of an adverse event due to ILE;
Patients with liver disease including cholestasis;
Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride >400 mg/dL);
Patients who are unable to tolerate the necessary laboratory monitoring;

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
ClinolipidLipid injectable emulsion, USP 20%	Drug	Clinolipid
IntralipidStandard-of-Care Soybean Oil-Based Lipid Emulsion. 20% (lipid injectable emulsion, USP)	Drug	Intralipid

Primary outcome

Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
Time frame: Up to Day 90
Holman Index is the plasma Triene:Tetraene ratio, specifically 5,8,11-eicosatrienoic acid [mead acid] to 5,8,11,14 eicosatetraenoic acid [arachidonic acid, [ARA] ratio

21 secondary outcomes

Number of Participants to Develop Parenteral Nutrition-Associated Liver Disease (PNALD)
Time frame: Up to Day 90
Alkaline Phosphatase (ALP)
Time frame: Up to Day 90
Aspartate Aminotransferase (AST)
Time frame: Up to Day 90
Alanine Aminotransferase (ALT)
Time frame: Up to Day 90
Gamma-Glutamyl Transferase (GGT)
Time frame: Up to Day 90
Total Bilirubin
Time frame: Up to Day 90
Direct Bilirubin
Time frame: Up to Day 90
Stigmasterol Blood Level
Time frame: Up to Day 90
Campesterol Blood Level
Time frame: Up to Day 90
Sitosterol Blood Level
Time frame: Up to day 90
Cholesterol Blood Level
Time frame: Up to Day 90
Squalene Blood Level
Time frame: Up to Day 90
Calories Nutritional Intake
Time frame: Up to Day 90
Protein Nutritional Intake
Time frame: Up to Day 90
Lipid Nutritional Intake
Time frame: Up to Day 90
Carbohydrates Nutritional Intake
Time frame: Up to Day 90
Change in Length or Height (and Head Circumference for Infants <1 Year of Age) From Baseline
Time frame: Up to Day 90
Body Weight
Time frame: Up to day 90
Body Weight
Time frame: Upto Day 90
Number of Adverse Events of Special Interest
Time frame: Up to Day 120 (30 Days After Subject's Last Study Treatment if hospital discharge has not occurred)
Number of Participants With Neonatal Morbidities
Time frame: Up to Day 90

Results and safety

Results posted to the registry on 27 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clinolipid (Lipid Injectable Emulsion) 20%	50	50
Intralipid (SOC Soybean Oil-based Lipid Emulsion)	51	50

Primary outcome: Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4

Time frame: Up to Day 90. Count of participants. Unit: Participants

Measure	Clinolipid (Lipid Injectable Emulsion) 20% n = 50	Intralipid (SOC Soybean Oil-based Lipid Emulsion) n = 51
Value	0	0

Population analysed: Full analysis set: all patients who are randomized to receive either Clinolipid or SoC SO-based lipid emulsion (Intralipid) and have received at least 1 randomized study treatment. Per protocol set: all patients in the FAS who have Holman Index measurements taken at baseline and at least 1 other timepoint post-baseline, who have received a minimum of 7 days of ILE treatment, and are without a major protocol violation (i.e., violation that potentially impacts the primary endpoint).

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to day 120. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinolipid (Lipid Injectable Emulsion) 20%	2 of 50 (4%)	40 of 50 (80%)	1 of 50
Intralipid (SOC Soybean Oil-based Lipid Emulsion)	2 of 51 (3.9%)	39 of 51 (76.5%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40415417Blanco C, Chang W, Bhatt AJ, Gerday E, Talati AJ, Dereddy N, Singh R, Ryan E, Senterre T. Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Aug;81(2):314-323. doi: 10.1002/jpn3.70072. Epub 2025 May 25.
Individual participant dataSharing planned: No

Related trials for Essential Fatty Acid Deficiency (EFAD)

RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
RecruitingObservational study
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency

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.

Baxter Healthcare Corporation study director

Baxter Healthcare Corporation

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clinolipid and Intralipid in people with Essential Fatty Acid Deficiency (EFAD), run by Baxter Healthcare Corporation at 9 sites in United States.

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 4 inclusion and 13 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4 (time frame: Up to Day 90). 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 NCT04555044, which also lists 1 linked publication.

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 27 Dec 2023.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (4 listed)

Key exclusion criteria (13 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4

Adverse events

Research links

Related trials for Essential Fatty Acid Deficiency (EFAD)

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4

Adverse events