Clinical Trials

Multiple clinical trials and non-interventional studies evaluate beta carotene's therapeutic and nutritional utility in addressing vitamin A status, oxidative stress, diabetes mellitus, retinitis pigmentosa, tuberculosis, and neoplasm chemoprevention. Spanning Early Phase 1 through Phase 4, this research is primarily sponsored by academic institutions, university hospitals, and specialized research centers. Across these efforts, recruitment statuses encompass completed protocols, active non-recruiting cohorts, and studies enrolling by invitation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07509229 ENROLLING_BY_INVITATION
Retinitis Pigmentosa
Sheba Medical Center
 2026-07-26 PHASE1; PHASE2
NCT04587791 RECRUITING
Chronic Pain; Opioid Use Disorder
Yale University
 2021-12-08 EARLY_PHASE1
NCT06100432 ACTIVE_NOT_RECRUITING
Male Infertility
Duta Wacana Christian University
 2023-11-11 PHASE4
NCT05326971 Active not recruiting
HIV Infections|Weight Gain
Jussi Sutinen|Helsinki University Central Hospital|University of Helsinki
 2023-01-19 Phase 4
NCT05610137 Completed
Dietary Intake
Vanessa Corrales Agudelo|Vidarium Nutrition Health and Wellness Research Center
 2022-10-18 --
NCT04697355 COMPLETED
Energy Expenditure; Safety Issues; Glucose Metabolism
Pennington Biomedical Research Center
 2021-04-19
NCT04593524 COMPLETED
Tuberculosis
Universitas Sumatera Utara
 2019-05-14
NCT03366584 UNKNOWN
Hyaline Membrane Disease; Necrotizing Enterocolitis of Newborn
Indonesia University
 2017-01 PHASE4
NCT05840848 COMPLETED
Bioavailability
University of Hohenheim
 2017-11-21
NCT03005496 COMPLETED
PreTerm Birth
Indonesia University
 2017-01 PHASE4
NCT03492593 COMPLETED
Digestion Chambers; Stability and Metabolism of Carotenoids and Vitamin E
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
 2014-09
NCT02550483 COMPLETED
Healthy
USDA Beltsville Human Nutrition Research Center
 2015-09
NCT02210507 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2014-07
NCT02276014 COMPLETED
Beta-carotene Bioavailability; Vitamin A Deficiency
Newcastle-upon-Tyne Hospitals NHS Trust
 2012-04
NCT00808470 COMPLETED
Noise-Induced Hearing Loss
University of Michigan
 2008-10 PHASE2
NCT01321268 TERMINATED
Cellulite (Orange Peel Skin)
dsm-firmenich Switzerland AG
 2011-05
NCT01381276 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2011-06 PHASE2
NCT00270647 COMPLETED
Cancer; Prostate Cancer; Colorectal Cancer; Cardiovascular Disease; Eye Disease; Cognitive Decline
Brigham and Women's Hospital
 1997-07
NCT01420406 COMPLETED
Vitamin A Deficiency
USDA, Western Human Nutrition Research Center
 2010-06
NCT01477112 COMPLETED
Diabetes Mellitus; Oxidative Stress; Iron Metabolism Disorders
Instituto Venezolano de Investigaciones Cientificas
 2010-01
NCT00864188 COMPLETED
Skin Health
Société des Produits Nestlé (SPN)
 2009-02 PHASE1
NCT00569023 COMPLETED
Night Blindness
Sheba Medical Center
 2007-07
NCT00680212 COMPLETED
Vitamin A Deficiency
Tufts University
 2008-07 PHASE2
NCT00636038 COMPLETED
Vitamin A Status
Tufts University
 2008-01 PHASE1
NCT00198822 COMPLETED
Vitamin A Deficiency; Maternal Mortality; Infant Mortality
Johns Hopkins Bloomberg School of Public Health
 2001-08 PHASE3
NCT00000541 COMPLETED
Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
Brigham and Women's Hospital
 1993-05 PHASE2
NCT00712647 COMPLETED
Lung Cancer
Fred Hutchinson Cancer Center
 1985-05 PHASE4
NCT00197743 COMPLETED
HIV Infections; Disease Transmission, Vertical
Harvard School of Public Health (HSPH)
 1995-04 PHASE3
NCT00169845 COMPLETED
Neoplasms
Laval University
 1994-10 PHASE3
NCT00128752 COMPLETED
Healthy
Radboud University Medical Center
 2003-03
NCT00000161 UNKNOWN
Macular Degeneration; Cataract
National Eye Institute (NEI)
 1993-08 PHASE3
NCT00128804 COMPLETED
Healthy; Ileostomy
Radboud University Medical Center
 2004-07
NCT00272428 COMPLETED
Healthy
Institut National de la Santé Et de la Recherche Médicale, France
 1994-10 PHASE3
NCT00000539 COMPLETED
Arterial Occlusive Diseases; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Diabetes Mellitus
National Heart, Lung, and Blood Institute (NHLBI)
 1992-09 PHASE3
NCT00000152 UNKNOWN
Macular Degeneration
National Eye Institute (NEI)
 1982-04 PHASE3
NCT00275418 UNKNOWN
Crohn's Disease
Bnai Zion Medical Center
 2002-07 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-27)

Check the Beta Carotene product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a lipophilic provitamin A carotenoid, beta carotene undergoes enzymatic cleavage to yield active retinoids while directly quenching singlet oxygen and scavenging reactive oxygen species to preserve cellular membrane lipid integrity. This antioxidant activity and retinoid receptor activation attenuate pro-inflammatory signaling and protect cells from oxidative stress, providing the mechanistic basis for its clinical evaluation in neoplasms, retinitis pigmentosa, and metabolic disorders.

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.