Investigation on the influence of royal jelly oral intake for endothelial cell function in patients with hemodialysis

JRCT ID: jRCTs071200031

Registered date:24/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hemodialysis
• Date of first enrollment: 10/12/2020
• Target sample size: 270
• Study type: Interventional
• Intervention(s): Double blind randomized

Outcome(s)

• Primary Outcome: Levels of flow mediated dilation at 0 and 24 months after stating of the treatment

Secondary Outcome

1. Levels of flow mediated dilation at 0, 6, 12, and 18 months after stating of the treatment
2. Levels of aort0carcification index at 0, 12, 24 months after stating of the treatment
3. Number of endothelial stem cell in the blood at 0, 3, 6, 9, 12, 15, 18, 21, 24 months after stating of the treatment
4. Serum levels of VEGF, MCSF, 8-OHdG, MDA at 0, 3, 6, 9, 12, 15, 18, 21, 24 months after stating of the treatment
5. Incidence of cardiovascular diseases, cerebrovascular diseases, and stenosis of blood access during the 24 months.
6. Adverse events of oral intake of royal jelly.

Key inclusion & exclusion criteria

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

Include criteria

1. Hemodialysis caused by chronic renal failure
2. Over 24 months survival after the treatment is expected.
3. Performance status is 0 - 2.
4. Age is 20 years and more.
5. Informed consent was obtained by the patient.
6. Understanding of the facts that all examinations, procedure, and treatments caused by hemodialysis were performed by Japan medical care, and that there is no compensation about the symptoms, disease and disorders in this trial.

Exclude criteria

1.Have already intake of royal jelly or bee-original foods
2.Have plan to buy and take of royal jelly in future
3.Have complication of severe blood diseases that are needed the treatment.
4.Have allergy against royal jelly or bee-original foods
5.Have a history of asthma and atopic disease
6.During pregnancy or breast-feeding
7.Principle investigator or co-investigators judged as inappropriate for this study.

Related Information

• Primary Sponsor: Ohba Kojiro
• Source(s) of Monetary Support: Yamada Research Grant,Yamada Research Grant