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5-ALA malaria asymptomatic study in Laos

Double blind, parallel, randomized, placebo controlled research to evaluate safety and efficacy of the 5-aminolevulinic phosphate (5-ALA PO4), sodium ferrous citrate (SFC) and zinc (Zn) with asymptomatic malaria parasite carriers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030190143
Enrollment
200
Registered
2019-11-27
Start date
2019-11-27
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

Asymptomatic Plasmodium carrier (healthy people) Asymptomatic Plasmodium carrier

Interventions

Administration of 5-aminolevulinic phosphate (5-ALA PO4) with sodium ferrous citrate (SFC) and zinc (Zn) to Asymptomatic Plasmodium carriers (healthy people)

Sponsors

Kano Shigeyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Participant who is able to give written informed consent 2.Male or female subject of 18 year to 65 year inclusive 3.Weighing 35 to 90 kg 4.Presence of malaria parasite of all species inclusive in blood confirmed by DNA amplification test 5.Women with child bearing potential willing to give consent for pregnancy test

Exclusion criteria

Exclusion criteria: 1.Participant with signs and symptoms of malaria 2.Known history of hypersensitivity, allergic or adverse reactions to 5-aminolevulinic acid, sodium ferrous citrate and Zn 3.Participant is pregnant or lactating women 4.Have taken any medication with antimalarial or antibiotic with antimalarial effect in previous 30 days

Design outcomes

Primary

MeasureTime frame
Putative time-dependent decrease of Plasmodium DNA in the 5-ALA group compared to the placebo group at 3 months following enrolment as detected by DNA diagnostic method.

Secondary

MeasureTime frame
HbA1c level at 1, 2, 3 months following enrolment

Countries

Japan, Laos

Contacts

Public ContactMoritoshi Iwagami

Research Institute, National Center for Global Health and Medicine

miwagami@ri.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

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