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Oral selenium supplementation study for selenium-deficiency patient with intestinal failure

Oral selenium supplement study (OSSS)

Kawaguchi Yunosuke

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

yunosuke.kawaguchi@chiba-u.jp

Kawaguchi Yunosuke

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

+81-43-222-7171

yunosuke.kawaguchi@chiba-u.jp

Recruiting

Sept. 07, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients with intestinal failure (short bowel syndrome, Allied disorders of Hirschsprung's disease, etc.) who received home parenteral nutrition or enteral nutrition.
2) Patients with selenium dificiency (seleum under the threshold) at the time of screening test.
3) Male or female patients aged 18-79 years at informed consent
4) Patients whose enteral nutrition is expected to remain unchanged after study drug administration.
5) Participants have signed informed consent forms.

1) Patients who changed their nutritional method within 4 weeks prior to the administration.
2) Patients who have taken the intravenous selenium products or the foods intended to supplement for selenium with in 4 weeks prior to the administration.
3) Patients with hypersensitivity to selenium or other constituents
4) Patients who have been or are currently undergoing treatment for arrhythmia
5) Patients with renal dysfunction (creatinine clearance < 30 mL/min or eGFR < 30 mL/min/1.73 m2)
6) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
7) Patients who are judged to be unsuitable for the safe conduct of this study.

Both

Selenium deficiency

Study drug dosing 97.5 mcg/1 tablet (4 weeks) will be initiated (cohort 1).
Four weeks after the start of treatment, the patients will be evaluated for adverse events and abnormally high serum selenium levels. An additional 4week postdose observation period will follow. Thereafter, an Independent Data Monitoring Committee will meet to discuss whether the study can be continued.
If it is determined that the study can be continued, subjects with serum selenium levels below the reference level after 4 weeks of oral administration will be transferred to Cohort 2. On the other hand, subjects whose serum selenium level rises above the reference level after 4 weeks of oral administration will be terminated from the study.
In Cohort 2, the study drug will be increased to 195 mcg/2 tablets and taken for 4 weeks. An additional 4week postdose observation period will follow. Subjects whose serum selenium levels are still below the threshold at the 4-week blood draw will be moved to Cohort 3. On the other hand, subjects whose serum selenium level rises above the reference level in the blood test after 4 weeks of oral administration will be terminated from the study.
In Cohort 3, the dose of study drug will be increased to 292.5 mcg/3 tablets for 4 weeks and the study will end after a 4-week post-dose observation period.

selenium

D012643

With regard to adverse events that occurred after the study drug administration, the number of patients with adverse events, the number and frequency of adverse events, and the number and frequency of adverse events with or without a causal relationship will be examined.
For adverse events (adverse drug reactions) for which a causal relationship cannot be ruled out, we will also tabulate the number of adverse events by the degree of causality.

Percentage of serum selenium values reaching the lower limit of reference values, test values and changes in serum selenium each week, test values and changes in urinary selenium levels each week, and percentage improvement in clinical findings (nails, hair, muscle pain)

+81-43-226-2616

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