Selenium DeficiencyNCT03448588
Research on Association Between Selenium Deficiencies and Change of Thyroid Function
An observational study of Selenium Deficiency, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Selenium Deficiency
- What is being tested?
- detection of serum selenium
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be recruited from volunteers who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.
Who may be able to join
- with normal free triiodothyronine( FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH).
- without thyroid hormone replacement therapy
- without medical history of thyroid surgery
- without iodine radiotherapy;
Who cannot join
- acute critical illness in the latest 1 year;
- weight fluctuation by more than 5% in the latest 3 months;
- eating disorders
- neuropsychological disorders
- allergy to corn or yeast
- fail to give informed consents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
yanping liu, master, 861069159081, liuyp1227@vip.sina.com
About this study
Official title: Effect of Selenium Deficiency on Thyroid Function
As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Previous literature has disclosed effect of selenium deficiency on inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the association between selenium deficiency and abnormally elevated T4 or T4/T3, which may provide more clues for establishing effective selenium assesment methods.
- Conditions
- Selenium Deficiency
- Being tested
- detection of serum selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of serum seleniumDiagnostic test
For this case-control study, no intervention will be administered to participants, only serum sample will be collected for selenium assessment
| Study group | Role | What they receive |
|---|---|---|
| group with normal T4 level or T4/T3 | participants with T4 within 4.3-12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) ≤7.52, which are considered to be normal T4 level and T4/T3. Receives: Diagnostic Test: detection of serum selenium | |
| group with elevated T4 level or T4/T3 | participants with T4 more than 12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) > 7.52, which are considered to be elevated T4 level and T4/T3. Receives: Diagnostic Test: detection of serum selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
between-group difference in serum selenium
comparison of the mean serum selenium between the two groups
Measured: up to 24 weeks
Secondary outcomes (2)
between-group difference in serum deiodinase activity
comparison of the mean deiodinase activity between the two groups
Measured: up to 24 weeks
between-group difference in erythrocyte glutathione peroxidase activity
comparison of the mean erythrocyte glutathione peroxidase activity between the two groups
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selenium DeficiencyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuyanping, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448588
- Sponsor's protocol ID
- Liuyanping3
- Status last verified
- May 2018
- First submitted
- 7 Feb 2018
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Selenium Deficiency on Thyroid Function
- ClinicalTrials.gov ID
- NCT03448588
- Acronym / sponsor ID
- Liuyanping3
- Conditions
- Selenium Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Previous literature has disclosed effect of selenium deficiency on inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the association between selenium deficiency and abnormally elevated T4 or T4/T3, which may provide more clues for establishing effective selenium assesment methods.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with normal T4 level or T4/T3 | – | Diagnostic Test: detection of serum seleniumparticipants with T4 within 4.3-12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) ≤7.52, which are considered to be normal T4 level and T4/T3. |
| group with elevated T4 level or T4/T3 | – | Diagnostic Test: detection of serum seleniumparticipants with T4 more than 12.5ug/dl and ratio of T4/T3(T4(ug/dl)/T3 (ng/ml)) > 7.52, which are considered to be elevated T4 level and T4/T3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from volunteers who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.
Key inclusion criteria (4 listed)
- with normal free triiodothyronine( FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH).
- without thyroid hormone replacement therapy
- without medical history of thyroid surgery
- without iodine radiotherapy;
Key exclusion criteria (6 listed)
- acute critical illness in the latest 1 year;
- weight fluctuation by more than 5% in the latest 3 months;
- eating disorders
- neuropsychological disorders
- allergy to corn or yeast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detection of serum seleniumFor this case-control study, no intervention will be administered to participants, only serum sample will be collected for selenium assessment | Diagnostic test | group with elevated T4 level or T4/T3, group with normal T4 level or T4/T3 |
Primary outcome
between-group difference in serum selenium
Time frame: up to 24 weeks
comparison of the mean serum selenium between the two groups
2 secondary outcomes
between-group difference in serum deiodinase activity
Time frame: up to 24 weeks
between-group difference in erythrocyte glutathione peroxidase activity
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: No
Related trials for Selenium Deficiency
Active, not recruiting
Different Diets in Different Diabetes - 4DI PLAN'EAT Pilot Study
Type 2 Diabetes
Active, not recruiting
Study Protocol: Cognitive, Emotional and Social Stimulation Programme for Low-SES Children.
Child Development, Socioeconomic Factors
Active, not recruitingObservational study
Selenium Levels in Patients With Abdominal Aneurysm
Abdominal Aneurysm, Selenium Deficiency
Not yet recruiting
Home-Based Language and Cognitive Intervention for Arab Toddlers in Israel
Enhancing Early Language and Cognitive Development in Toddlers Through a Culturally Adapted Home-based Parent Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Selenium Deficiency, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanping Liu (+861069159088, liuyp1227@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
between-group difference in serum selenium (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.