Clinical Trials

Numerous clinical trials ranging from Early Phase 1 through Phase 4 evaluate the therapeutic and nutritional applications of docosahexaenoic acid. Sponsored by industrial entities such as Fresenius Kabi alongside academic institutions like the Public Health Foundation of India, these studies address indications including metabolic syndrome, asthma, head trauma, retinitis pigmentosa, parenteral nutrition-associated liver disease, essential fatty acid deficiency, metastatic breast cancer, and maternal-infant nutrition. The overall landscape encompasses completed, actively recruiting, active non-recruiting, and terminated or withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03965988 RECRUITING
Breath Holding Attack
Sherief Abd-Elsalam
 2018-05-01 PHASE3
NCT06494488 RECRUITING
Lipid Metabolism Disorders; Hypertriglyceridemia
The Miriam Hospital
 2025-07-10 EARLY_PHASE1
NCT05380401 RECRUITING
Premature
The University of Texas Health Science Center at San Antonio
 2023-03-09
NCT03838536 RECRUITING
Breastfeeding, Exclusive
University of North Carolina, Chapel Hill
 2019-02-05
NCT07042009 RECRUITING
Docosahexaenoic Acid Content of the Participants; Docosahexaenoic Acid Content of the Breast Milk
University of Roehampton
 2026-04-02
NCT06928701 RECRUITING
Early Breast Cancer; Neoadjuvant Treatment
University of Eastern Piedmont
 2024-09-01
NCT05802797 ACTIVE_NOT_RECRUITING
Healthy Diet
Ohio State University Comprehensive Cancer Center
 2023-04-03 EARLY_PHASE1
NCT07346703 ENROLLING_BY_INVITATION
Multiple Sclerosis; Performance Enhancement; Supplemental Nutrition Assistance Program Education; Strength Outcomes; Function Improvement; Intervention Study
Francisco Javier Martínez Noguera
 2026-01
NCT05841927 ACTIVE_NOT_RECRUITING
Autism or Autistic Traits
Children's Hospital of Fudan University
 2020-12-01
NCT06366893 UNKNOWN
Infant, Premature, Diseases
Hospital Universitari Vall d'Hebron Research Institute
 2024-03-04
NCT06294067 COMPLETED
Nutrition, Healthy
University of Toronto
 2024-02-26 PHASE1
NCT03831178 ACTIVE_NOT_RECRUITING
Breast Cancer
AHS Cancer Control Alberta
 2019-08-28 PHASE2
NCT06302023 COMPLETED
Pregnant Women Diagnosed With Threatened Preterm Labor
Khon Kaen University
 2024-04-01 PHASE2
NCT04496817 UNKNOWN
Diabetic Retinopathy; Type 2 Diabetes
University of Manitoba
 2022-07-11
NCT03402789 WITHDRAWN
Amblyopia
Johns Hopkins University
 2024-01-01 PHASE1; PHASE2
NCT05191823 ACTIVE_NOT_RECRUITING
Preterm Birth; Child Development
Sarah Keim
 2021-12-01
NCT05763940 UNKNOWN
Dry Eye Syndromes; Age-Related Macular Degeneration; Omega 3 Index
Western University of Health Sciences
 2022-05-25
NCT06274788 Not yet recruiting
Parenteral Nutrition Associated Liver Disease (PNALD)|Essential Fatty Acid Deficiency|Malnutrition|Pediatric ALL
Fresenius Kabi
 2024-05-01 Phase 4
NCT06319079 Not yet recruiting
Lactating Mothers|Infants
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
 2024-03 Not Applicable
NCT05915806 ACTIVE_NOT_RECRUITING
Bronchopulmonary Dysplasia; Child Development; Neonatal and Perinatal Conditions
CHU de Quebec-Universite Laval
 2023-07-30
NCT03972319 UNKNOWN
Fatty Liver; Bariatric Surgery Candidate
Khoo Teck Puat Hospital
 2019-09-17 EARLY_PHASE1
NCT04198805 COMPLETED
Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Fatty Liver; Non-Alcoholic Steatohepatitis
Naga P. Chalasani
 2020-01-03 PHASE2
NCT05527106 COMPLETED
Glaucoma
Institut Catala de Retina
 2015-03-12
NCT05756062 COMPLETED
Keratoconus
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
 2019-02-01
NCT05335863 COMPLETED
Healthy
Instituto de Investigación Hospital Universitario La Paz
 2021-11-03
NCT03194659 UNKNOWN
Pregnancy
Cornell University
 2017-10-05
NCT04151758 UNKNOWN
Childhood Obesity
University of Milan
 2019-01-07 PHASE4
NCT04570995 TERMINATED
Brain Health; Brain Function; Brain Development
Wake Forest University Health Sciences
 2020-11-05
NCT04069195 UNKNOWN
Inflammation; Pregnancy Related
Walter Reed National Military Medical Center
 2019-02-01
NCT02626299 COMPLETED
Preterm Birth
University of Kansas Medical Center
 2016-06-08 PHASE3
NCT02709239 COMPLETED
Use and Dose of Prenatal DHA Supplementation
University of Kansas Medical Center
 2016-06-01
NCT04242004 UNKNOWN
Neurocognitive Impairment
Fudan University
 2019-10-30 PHASE1; PHASE2
NCT04987567 COMPLETED
Cystic Fibrosis in Children
Corporacion Parc Tauli
 2018-03-21
NCT04796207 COMPLETED
Traumatic Brain Injury (TBI); Chronic Traumatic Encephalopathy (CTE)
University of Arizona
 2019-05-28
NCT03915535 TERMINATED
Healthy Athletes
Samuel Fortin
 2019-09-19 PHASE4
NCT04438928 COMPLETED
Healthy Pregnant Women
Bayer
 2016-09-27
NCT04462939 COMPLETED
Healthy Lactating Mother
Bayer
 2017-04-26
NCT03700957 UNKNOWN
Necrotizing Enterocolitis
Ain Shams University
 2018-10
NCT03781557 UNKNOWN
Cognition; Brain; Neuroscience
Sulaiman AlRajhi Colleges
 2019-01-01 PHASE4
NCT03072277 COMPLETED
Pregnancy
Public Health Foundation of India
 2015-12 PHASE3
NCT03045198 UNKNOWN
Cystic Fibrosis
University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)
 2012-03 PHASE4
NCT02541929 COMPLETED
Brain Health
University of Southern California
 2016-06-30 PHASE2; PHASE3
NCT02947100 TERMINATED
Sickle Cell Disease
Robin E. Miller
 2018-01-25 PHASE1; PHASE2
NCT03582267 COMPLETED
Head Trauma
Texas Christian University
 2017-08-01
NCT01251887 COMPLETED
Weight Gain; Healthy Subjects; Obesity; Women
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2010-11-12
NCT01732874 COMPLETED
Docosohexaenoic Acid Supplementation of Mothers to
Children's Hospital Medical Center, Cincinnati
 2013-05 PHASE1; PHASE2
NCT04128449 COMPLETED
Performance
Universidad Católica San Antonio de Murcia
 2018-04-01
NCT03443076 COMPLETED
Bioavailability
Midwest Center for Metabolic and Cardiovascular Research
 2018-02-16
NCT02336243 UNKNOWN
Premature Birth; Preeclampsia; Fetal Growth Retardation; Stillbirth
Pontificia Universidad Catolica de Chile
 2015-05 PHASE3
NCT02848469 UNKNOWN
Psychotic Disorders
University College Cork
 2013-09 PHASE2
NCT02472171 COMPLETED
Inflammation
USDA, Western Human Nutrition Research Center
 2015-06
NCT02683317 COMPLETED
Retinopathy of Prematurity
Coordinación de Investigación en Salud, Mexico
 2016-02-22
NCT01745510 COMPLETED
Necrotizing Enterocolitis
Coordinación de Investigación en Salud, Mexico
 2012-10 PHASE1; PHASE2
NCT02973360 UNKNOWN
Sickle Cell Disease
Micelle BioPharma Inc
 2017-03-02 PHASE2
NCT02517502 COMPLETED
Cognitive Dysfunction
Carol Fabian, MD
 2015-07 EARLY_PHASE1
NCT01903525 COMPLETED
Concussion; Mild Traumatic Brain Injury
University of Texas Southwestern Medical Center
 2013-09 PHASE1
NCT01814527 COMPLETED
Mild Concussion; Brain Concussion; Cerebral Concussion
East Carolina University
 2013-07
NCT01576783 COMPLETED
Preterm Birth; Child Development
Sarah Keim
 2012-04-26 PHASE4
NCT01883817 COMPLETED
Attention Deficit Disorder
University of Cincinnati
 2013-09 PHASE3
NCT01580345 COMPLETED
Pregnancy
Centre for Chronic Disease Control, India
 2015-12 PHASE3
NCT01051154 COMPLETED
Acute Lymphoblastic Leukemia; Malnutrition
Coordinación de Investigación en Salud, Mexico
 2010-09 PHASE2
NCT00982462 COMPLETED
Infant Development
Retina Foundation of the Southwest
 2011-01-20
NCT01563913 COMPLETED
Parkinson's Disease
VA Office of Research and Development
 2012-10 PHASE1
NCT01849250 COMPLETED
Benign Breast Neoplasm; Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Lobular Breast Carcinoma In Situ; Paget Disease of the Breast; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
National Cancer Institute (NCI)
 2013-05 PHASE2
NCT02137408 WITHDRAWN
Hypertension in Pregnancy
Children's Hospital Medical Center, Cincinnati
 2014-12
NCT02195609 COMPLETED
Menopause; Hot Flashes
Instituto Palacios
 2014-03 PHASE4
NCT03956433 COMPLETED
Metabolic Syndrome
University of Leeds
 2014-09-01
NCT02098317 COMPLETED
NAFLD; Non Alcoholic Steatohepatitis (NASH)
Bambino Gesù Hospital and Research Institute
 2014-01 PHASE3
NCT01828944 COMPLETED
Osteopenia; Sarcopenia
Lesieur
 2012-12
NCT02865044 COMPLETED
Healthy
Calanus
 2015-03
NCT01796262 COMPLETED
Attention Deficit Hyperactivity Disorder
IRCCS Eugenio Medea
 2012-06 PHASE3
NCT01846325 COMPLETED
Asthenozoospermia
National Nutrition and Food Technology Institute
 2013-12 PHASE2; PHASE3
NCT01783613 COMPLETED
Cystic Fibrosis
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
 2011-10
NCT01865448 COMPLETED
Obesity; Inflammation
Protein Supplies SL
 2013-05
NCT01934777 COMPLETED
Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
Bambino Gesù Hospital and Research Institute
 2013-10 PHASE3
NCT01548534 TERMINATED
Metastatic Breast Cancer; Progesterone Receptor Positive Tumor; Estrogen Receptor Positive Tumor; HER-2 Negative Tumor
University Hospital, Tours
 2012-02 PHASE3
NCT01897948 TERMINATED
Measurement of Docosahexaenoic Acid Levels in Pre-school Children
Mead Johnson Nutrition
 2013-07
NCT01908907 COMPLETED
Prematurity
Sanford Health
 2012-10
NCT01908374 UNKNOWN
Hypertriglyceridemia
Arctic Nutrition AS
 2013-07
NCT02859129 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2013-09 PHASE1
NCT01284660 COMPLETED
HEAVY TOBACCO SMOKERS
Hillel Yaffe Medical Center
 2011-11
NCT02005900 COMPLETED
HIV-associated Hypertriglyceridemia; HIV-associated Hypercholesterolemia; HIV-associated Inflammatory State
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2011-06 PHASE3
NCT01127867 COMPLETED
Breast Cancer; Obesity
Rockefeller University
 2010-05
NCT00361374 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2006-07 PHASE3
NCT01150292 COMPLETED
Type 2 Diabetes
Hospices Civils de Lyon
 2010-05
NCT01554462 COMPLETED
Attention Deficit Hyperactivity Disorder; Healthy
Unilever R&D
 2009-01
NCT01078909 COMPLETED
Cardiovascular Disease; Inflammation
Penn State University
 2011-10 PHASE3
NCT00345176 COMPLETED
Age-related Macular Degeneration; Cataract
National Eye Institute (NEI)
 2006-09 PHASE3
NCT01062373 TERMINATED
Premature
Institut National de la Santé Et de la Recherche Médicale, France
 2010-02
NCT00100230 COMPLETED
Retinitis Pigmentosa; X-linked Genetic Diseases
Retina Foundation of the Southwest
 2004-09 PHASE2
NCT00325013 COMPLETED
Primary Sclerosing Cholangitis; Colitis
Beth Israel Deaconess Medical Center
 2005-12 PHASE1
NCT01202812 UNKNOWN
Sickle Cell Disease; HEMOGLOBIN SS; Hemoglobin S Beta-0 Thalassemia; Inflammation; Quality of Life
Thomas Jefferson University
 2010-10 PHASE2
NCT02177383 COMPLETED
Oxidative Stress; Exercise; Training Season; Antioxidant Capabilities; Athletic Performance
University of the Balearic Islands
 2011-09
NCT00620672 COMPLETED
Pregnancy
University of British Columbia
 2004-05 PHASE1
NCT00530244 COMPLETED
Cystic Fibrosis
University of Massachusetts, Worcester
 2003-03
NCT01431690 COMPLETED
Hypertriglyceridemia
AstraZeneca
 2011-08 PHASE1
NCT01976806 COMPLETED
Periodontitis; Gingivitis; Inflammation
Beth Israel Deaconess Medical Center
 2009-06 PHASE2
NCT01558193 COMPLETED
Aggression
Swansea University
 2011-03
NCT01400490 UNKNOWN
Heart Disease
Cardiovascular Research Associates
 2010-09
NCT00909012 COMPLETED
Phenylketonuria
Ludwig-Maximilians - University of Munich
 2009-05
NCT01066182 COMPLETED
Learning; Behaviour
University of Oxford
 2009-01 PHASE2
NCT01049529 COMPLETED
Severe Sepsis; Organ Dysfunction Syndrome
Coordinación de Investigación en Salud, Mexico
 2007-03 PHASE2
NCT00871377 COMPLETED
Epilepsy
National Center for Complementary and Integrative Health (NCCIH)
 2008-05 PHASE2
NCT01007110 COMPLETED
Pregnancy
University of Kansas
 2009-05 PHASE3
NCT05415293 TERMINATED
Randomized Clinical Trial; Docosahexaenoic Acid; Pregnancy
University of New Mexico
 2011-05
NCT01192269 COMPLETED
Healthy
Ludwig-Maximilians - University of Munich
 2010-08
NCT01200446 COMPLETED
Asthma
Indiana University
 2010-10
NCT01048970 UNKNOWN
Lung Cancer
National Institute of Cancerología
 2009-10 PHASE2; PHASE3
NCT00487097 COMPLETED
Pressure Sores; Intensive Care
Rabin Medical Center
 2007-09
NCT02690857 COMPLETED
Cystic Fibrosis
Hospices Civils de Lyon
 2010-05 PHASE2
NCT00885313 COMPLETED
Fatty Liver; Liver Fibrosis; Obesity; Metabolic Syndrome; Nonalcoholic Fatty Liver Disease
Bambino Gesù Hospital and Research Institute
 2009-03 PHASE1; PHASE2
NCT00621634 WITHDRAWN
Tardive Dyskinesia
Université de Montréal
 2008-02 PHASE2
NCT00892554 COMPLETED
Phenylketonuria
Emory University
 2007-06
NCT00749307 COMPLETED
Arrhythmia
Campus Bio-Medico University
 2008-06 PHASE2; PHASE3
NCT00886704 COMPLETED
Atherosclerosis
Ludwig-Maximilians - University of Munich
 2009-04
NCT00691418 WITHDRAWN
Premature Birth
Kaiser Permanente
 2008-07
NCT00440050 COMPLETED
Alzheimer's Disease
Alzheimer's Disease Cooperative Study (ADCS)
 2007-02 PHASE3
NCT00455416 UNKNOWN
Follicular Lymphoma
Oslo University Hospital
 2007-04 PHASE2
NCT00014027 COMPLETED
Healthy
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 2001-04-04 PHASE1
NCT00662142 COMPLETED
Healthy; Attention
University of Cincinnati
 2006-01 PHASE3
NCT00577447 COMPLETED
Autism
Mayo Clinic
 2005-10
NCT01174134 COMPLETED
Levels of DHA in the Blood
Mead Johnson Nutrition
 2006-07
NCT00610922 COMPLETED
Healthy
University of Milan
 2005-05
NCT00678067 COMPLETED
Hypercholesterolemia
University of Milan
 2005-06
NCT01180933 COMPLETED
Perinatal DHA and Folate Status; Neurological Development
Ludwig-Maximilians - University of Munich
 2001-11
NCT00000116 COMPLETED
Retinitis Pigmentosa
Carol Weigel DiFranco
 1996-05 PHASE3
NCT01300130 COMPLETED
Prematurity of Fetus
Ludwig-Maximilians - University of Munich
 1995-06
NCT00004827 COMPLETED
Retinitis Pigmentosa
Retina Foundation of the Southwest
 1996-03
NCT00060749 COMPLETED
Macular Degeneration
National Eye Institute (NEI)
 2003-05-05 PHASE1
NCT00360217 COMPLETED
Hypertriglyceridemia (TG>200<500); Hyperlipidemia; Coronary Artery Disease; Coronary Risk Equivalent; Diabetes
Maine Center for Lipids and Cardiovascular Health
 2006-01

(data from https://clinicaltrials.gov, updated on 2019-05-29)

Check the DHA (Docosahexaenoic Acid) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Docosahexaenoic acid incorporates into cellular phospholipid bilayer membranes, modulating membrane fluidity and disrupting downstream pro-inflammatory eicosanoid signaling cascades. This cellular membrane alteration reduces inflammatory mediator secretion and promotes structural stability in neural tissues, providing therapeutic relevance in clinical studies assessing neurodevelopment, metabolic syndrome, and inflammatory disorders such as asthma and parenteral nutrition-associated liver disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.