Oral selenium supplement study

Phase 1

Recruiting

• Conditions: Selenium deficiency; selenium; D012643

• Registration Number: JPRN-jRCTs031220321
• Lead Sponsor: Terui Keita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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 Outcome Measures

Name	Time	Method
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)