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

Oral selenium supplement study (OSSS)

3

Two males and one female participated in this study, with ages of 36, 38, and 43 years. One patient had been diagnosed with short bowel syndrome, while the other two had chronic idiopathic pseudo-intestinal obstruction. Two of the patients had an enterostomy.All patients were receiving home parenteral nutrition, with daily intravenous nutrient volumes of 1,600 ml, 2,000 ml, and 2,400 ml, and corresponding caloric intakes of 696 kcal, 1,160 kcal, and 1,640 kcal, respectively. None of the patients were using enteral nutrition for nutritional supplementation.

Consent was obtained from three patients. All three were screened, found eligible, and enrolled in the study. In Cohort 1, patients took one capsule of selenium supplementation daily for four weeks. One patient developed an elevated serum selenium level, leading to the study's termination at this stage. The remaining two patients proceeded to Cohort 2, where they took two capsules daily for four weeks. At this stage, one of the two patients also developed an elevated serum selenium level, resulting in the study's termination for this cohort. The last remaining patient advanced to Cohort 3, taking three capsules of selenium supplementation daily for four weeks. Two patients experienced adverse events; one occurred at the end of her supplementation period but improved after completion, allowing the study to continue. Following a four-week observation period after Cohort 3, the study was officially terminated for all three patients.

Three adverse events occurred in two patients. One patient developed increased drainage from the enterostomy (mild) and nausea (mild) after four weeks of treatment. Since the nausea occurred near the end of supplementation, the study drug was discontinued, and the symptoms subsequently improved. The other patient developed a fever (moderate) accompanied by a sore throat and nasal discharge while on selenium supplementation. An upper respiratory tract infection was suspected; however, CRBSI could not be ruled out, and the patient was hospitalized for treatment. Blood cultures taken at the time of fever were negative. The fever resolved, and antimicrobial therapy was discontinued, allowing the patient to be discharged. Given the presence of clear upper respiratory symptoms, selenium supplementation was not discontinued, and the patient continued to be monitored.

The primary endpoints were evaluated based on the number of adverse events, frequency of adverse events, and causality. Adverse Events: A total of three adverse events occurred in two patients. One patient developed increased drainage from the enterostomy (mild severity) and nausea (mild severity) after four weeks of treatment. These events were considered causally related to selenium supplementation. The other patient developed a fever (moderate severity) accompanied by a sore throat and nasal discharge while on selenium supplementation. An upper respiratory tract infection was suspected; however, CRBSI could not be ruled out, and the patient was hospitalized for treatment. Blood cultures taken at the time of fever were negative, and the fever resolved after antimicrobial therapy was discontinued. Given the presence of clear upper respiratory symptoms, selenium supplementation was not discontinued, and the patient continued to be monitored. This case was considered to have no causal relationship with selenium supplementation. No other adverse events were reported. Secondary Efficacy Endpoint: By Cohort 3, selenium blood levels had increased to normal levels in all patients, achieving an overall study attainment rate of 100%. Laboratory tests showed that serum and urinary selenium levels increased during the treatment period but decreased after treatment completion. None of the patients exhibited clinical signs of nail changes, hair changes, or myalgia before selenium capsule administration. Therefore, the improvement rate with selenium supplementation remained unknown. Secondary Safety Endpoint: No patients developed abnormally high serum selenium levels during the study.

This prospective study evaluated the safety of oral selenium supplementation in patients with intestinal failure and low selenium levels. Since selenium is a trace element supplement, no major adverse events were observed; however, caution should be exercised regarding potential side effects such as diarrhea and nausea. Despite impaired intestinal absorption, oral selenium supplementation may be an effective method for patients with intestinal insufficiency.

Mar. 31, 2026

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https://jrct.mhlw.go.jp/latest-detail/jRCTs031220321

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

Complete

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

Aug. 26, 2022

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