Oral selenium supplement study

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031220321

Enrollment

Registered

2022-09-07

Start date

2022-09-07

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

Selenium deficiency selenium

Interventions

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 seleniu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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)	—

Contacts

Public ContactYunosuke Kawaguchi

Chiba University Hospital

yunosuke.kawaguchi@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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