Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects

Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects - Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022825

Enrollment

Registered

2016-06-22

Start date

2016-08-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Subjects receive 250 mg/day of 5-aminolevulinic acid phosphate and 143.4 mg/day of sodium ferrous citrate (15 mg as Fe) for 28 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy

Exclusion criteria

Exclusion criteria: 1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) History of severe disease and/or major surgery 6) History of hypersensitivity caused by 5-aminolevulinic acid or porphyrin 7) Subject or family history of diagnosis of porphyria 8) Severe anemia (Hemoglobin < 10 g/dL) 9) Judged as ineligible by clinical investigators

Design outcomes

Primary

Measure	Time frame
Adverse event including laboratory abnormality and the change of CTCAE grade	—

Countries

Japan

Contacts

Public ContactFumiko Higashikawa

Hiroshima University, Institute of Biomedical & Health Sciences Project Research Center for Clinical Trial and Preventive Medicine

fumiko@hiroshima-u.ac.jp082-257-1533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026