Clinical Trials

Numerous clinical trials evaluate the utility of citric acid across diverse therapeutic and diagnostic applications, including urolithiasis, bowel preparation prior to colonoscopy, sleep apnea syndrome, chronic cough, head and neck cancer, and metabolic disturbances. These studies span Early Phase 1 to Phase 4 interventional and non-interventional protocols, exhibiting varied recruitment statuses including completed, recruiting, and not yet recruiting. Spearheaded by academic universities, medical centers, and pharmaceutical sponsors, these initiatives reflect a broad clinical research scope.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07700277 NOT_YET_RECRUITING
Lower Gastrointestinal Disorder; Tolerance
Ottawa Hospital Research Institute
 2026-08-01 EARLY_PHASE1
NCT07531901 RECRUITING
Cough Reflex Sensitivity
University of Montana
 2026-07-15
NCT05775614 ENROLLING_BY_INVITATION
Catheter Blockage
Odense University Hospital
 2022-05-01
NCT07708792 NOT_YET_RECRUITING
Gingival Pigmentation
Dijlah University
 2026-08
NCT07206524 RECRUITING
Hemodialysis; Thromboinflammation; Hemodialysis Complication; End Stage Renal Disease (ESRD)
Universitair Ziekenhuis Brussel
 2025-06-05
NCT05592327 UNKNOWN
Peri-Implantitis; Implant Infection; Microbial Disease
Universitat Internacional de Catalunya
 2022-11-03
NCT05918029 TERMINATED
Chronic Kidney Diseases; Bone Loss
Albert Einstein College of Medicine
 2024-08-15 PHASE2; PHASE3
NCT06580366 UNKNOWN
Bowel Preparation
Hitit University
 2024-08-22 PHASE4
NCT07162974 COMPLETED
Urolithiasis
Moscow State University of Medicine and Dentistry
 2023-01-01
NCT06386991 UNKNOWN
Endodontic Disease
TC Erciyes University
 2024-01-01 PHASE4
NCT04161599 UNKNOWN
Wounds and Injuries; Surgery--Complications
Hospital Universitari Vall d'Hebron Research Institute
 2022-03-01 PHASE4
NCT06994585 COMPLETED
Bowel Preparation
Fu Jen Catholic University Hospital
 2024-03-20
NCT03593252 UNKNOWN
Colostomy; Hirschsprung Disease - Pull Through; Necrotizing Enterocolitis; Inflammatory Bowel Diseases; Meconium Ileus; Bowel Obstruction; Elective Surgery
McMaster University
 2022-01-01
NCT01754779 COMPLETED
Calcium Phosphate Kidney Stones
University of Texas Southwestern Medical Center
 2012-07 PHASE2
NCT05319262 Completed
Noise Exposure|Sleep Disturbance|Sleep Hygiene|Metabolic Disturbance|Cognitive Change
Göteborg University|University of Pennsylvania|University of Manitoba
 2022-04-24 Not Applicable
NCT04741620 COMPLETED
Oropharyngeal Dysphagia; Dysphagia; Swallowing Disorder
Hospital de Mataró
 2019-01-17
NCT04700475 UNKNOWN
Head and Neck Cancer
Nada Yousef
 2020-09-04
NCT04033250 UNKNOWN
Inadequate Preparation for Colonoscopy; Personalized Colonoscopy Preparation
Rambam Health Care Campus
 2019-09
NCT03367494 TERMINATED
Cystic Fibrosis
Milton S. Hershey Medical Center
 2018-03-01
NCT03999203 COMPLETED
Asthma; Cough
Queen's University, Belfast
 2017-10-04
NCT03198221 TERMINATED
Bowel Preparation Solutions
The Cleveland Clinic
 2018-07-11 PHASE4
NCT03639727 COMPLETED
Chronic Cough
Kuopio University Hospital
 2018-09-01
NCT02359942 COMPLETED
Helicobacter Pylori Infection
Seoul National University Bundang Hospital
 2015-03-01
NCT03357068 COMPLETED
Alveolar Bone Atrophy; Bone Resorption
University of Sao Paulo
 2017-07-01
NCT03769402 COMPLETED
Intrabony Periodontal Defect
Ain Shams University
 2016-01-01 PHASE4
NCT03017235 COMPLETED
Bowel Preparation
Ferring Pharmaceuticals
 2017-02-20 PHASE3
NCT03095378 COMPLETED
Gingival Recession
University of Sao Paulo
 2014-03-10
NCT02919631 Unknown status
Glycogen Storage Disease Type V
Institut National de la Santé Et de la Recherche Médicale France|Rigshospitalet Denmark
 2016-10 Phase 2
NCT03007160 Unknown status
Urolithiasis
Dawnrays Pharmaceutical (Holdings) Limited
 2016-07 Phase 4
NCT02714075 COMPLETED
Iron Deficiency and/or Anemia
Swiss Federal Institute of Technology
 2016-04
NCT02386449 COMPLETED
Bowel Preparation
Ferring Pharmaceuticals
 2015-02 PHASE4
NCT02459756 COMPLETED
Vascular Stiffness; Inflammation
University of Reading
 2015-06
NCT02294838 UNKNOWN
Parotid Neoplasms
British Columbia Cancer Agency
 2014-12
NCT02039999 COMPLETED
Cough
Hull University Teaching Hospitals NHS Trust
 2015-02
NCT02152215 COMPLETED
Ridge Preservation
University of Louisville
 2014-07 PHASE4
NCT03578900 COMPLETED
Xerostomia; Hyposalivation; Quality of Life; Sjogren's Syndrome
Grupo de Investigação em Bioquímica e Biologia Oral
 2013-01-01 PHASE4
NCT03851393 COMPLETED
Cough
Hull University Teaching Hospitals NHS Trust
 2014-08
NCT01984008 COMPLETED
Bowel Preparation Before Colonoscopy
Universal Integrated Corp.
 2013-10-23 PHASE3
NCT02255812 COMPLETED
Exploratory Behavior
University Hospital, Basel, Switzerland
 2013-03
NCT01711437 UNKNOWN
Colonoscopy
Azienda Policlinico Umberto I
 2011-01 PHASE4
NCT02018315 COMPLETED
Glucose Transporter Type 1 Deficiency Syndrome; GLUT1 Deficiency Syndrome
Juan Pascual
 2012-01 PHASE1
NCT02259543 COMPLETED
Gingival Recession
University of Sao Paulo
 2011-08
NCT01481714 UNKNOWN
Bowel Cleansing; Colonoscopy
Infante, Javier Molina, M.D.
 2011-11 PHASE4
NCT01421160 WITHDRAWN
Arthritis
Texas Tech University Health Sciences Center, El Paso
 2011-07 PHASE1
NCT01012349 UNKNOWN
Treatment of Episodic Tension Headache
Azidus Brasil
 2011-02 PHASE2; PHASE3
NCT01260766 UNKNOWN
Acne Vulgaris
Oplon-Pure Science Ltd.
 2011-01 PHASE2
NCT01180543 COMPLETED
Acne Vulgaris
Oplon-Pure Science Ltd.
 2010-08 PHASE2
NCT01179633 COMPLETED
Acne Vulgaris
Oplon-Pure Science Ltd.
 2010-03 PHASE1; PHASE2
NCT01065857 COMPLETED
Subjects Undergoing a Complete Exploratory Diagnostic Colonoscopy for the First Time.
Laboratorios Casen-Fleet S.L.U.
 2010-01 PHASE3
NCT00586131 COMPLETED
End-stage Renal Disease
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2003-09 PHASE4
NCT02209714 COMPLETED
Healthy
Boehringer Ingelheim
 1999-11 PHASE1
NCT02199899 COMPLETED
Healthy
Boehringer Ingelheim
 1999-03 PHASE1
NCT00317083 COMPLETED
Sleep Apnea Syndrome
Bichat Hospital
 2001-11

(data from https://clinicaltrials.gov, updated on 2026-07-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Citric acid acts as a central intermediate in the tricarboxylic acid cycle and functions as a chelating agent that binds divalent cations such as calcium, thereby inhibiting calcium phosphate and oxalate crystallization in solution. This biochemical alkalization and chelation capacity modulates cellular metabolic flux and prevents stone formation, providing therapeutic relevance in clinical applications such as urolithiasis management and gastrointestinal bowel preparation regimens.

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.