5-ALA malaria asymptomatic study in Laos

JRCT ID: jRCT1030190143

Registered date:27/11/2019

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Asymptomatic Plasmodium carrier (healthy people)
• Date of first enrollment: 27/11/2019
• Target sample size: 200
• Countries of recruitment: Laos,Japan
• Study type: Interventional
• Intervention(s): Administration of 5-aminolevulinic phosphate (5-ALA PO4) with sodium ferrous citrate (SFC) and zinc (Zn) to Asymptomatic Plasmodium carriers (healthy people)

Outcome(s)

• Primary Outcome: 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 Outcome: HbA1c level at 1, 2, 3 months following enrolment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kano Shigeyuki