Efficacy of D-alanine intake in patients with chronic kidney disease; a randomized controlled pilot trial

JRCT ID: jRCTs041230148

Registered date:06/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 06/02/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): D-alanine 1 g, per oral, three times a day after each meal for 12 weeks

Outcome(s)

• Primary Outcome: Percentage change in urine albumin to creatine ratio from baseline to 12 weeks

Secondary Outcome

1) Changes in the variables from baseline to 12 weeks; blood glucose, HbA1c, blood pressure, BMI, estimated GFR, uric acid, fasting blood glucose, HbA1c, T-Cho, HDL-Cho, TG, urine protein/creatinine ratio, urine beta-2-microglobulin, urine NAG, urine MCP-1, sleep index, sarcopenia assessment, chiral amino acids (blood, urine, stool, saliva), 16S rRNA flora (stool, saliva)
2) Remission of albuminuria
3) Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included.
1) Patients who aged 20 years or older at the time of obtaining the informed consent.
2) Sustained urine protein to creatinine ratio higher than 0.5 g/gCr or urine albumin to creatine ratio higher than 300 mg/gCr for more than two consecutive visits
3) The written consent can be obtained after informed consent for participation in the study.

Exclude criteria

Patients who meet any of the following criteria are excluded.
1) Patients undergoing dialysis therapy
2) Pregnant or lactating mothers
3) Patinets who take antimicrobials or medications for intestine disorders including lactobacillus preparations
4) Patients who take food for specified health uses or food with functional claims that labels the improvement of the intestinal environment at the study entry
5) Initiation of SGLT2 inhibitors within 8 weeks prior to the study entry
6) Initiation of RAS blockers within 8 weeks prior to the study entry
7) Participation in other clinical studies within 8 weeks prior to the study entry
8) Not appropriate as participants

Related Information

• Primary Sponsor: Oshima Megumi
• Secondary Sponsor: Yasunori Iwata
• Source(s) of Monetary Support: KAGAMI Inc
• Secondary ID(s): Nil known