Selenium DeficiencyNCT03445078
Correction of Selenium Deficiency Has Effect on Thyroid Function
A study testing selenium supplementation and ordinary corn powder in people with Selenium Deficiency, run by Peking Union Medical College Hospital.
Trial summary
Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Selenium Deficiency
- What is being tested?
- selenium supplementation and ordinary corn powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Apr 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study
- Should have stable body weight in the latest 3 months;
- Should be not prescribed with thyroid hormone replacement therapy
- Should be without medical history of thyroid surgery or iodine radiotherapy
- Should have normal FT3, FT4 and TSH.
Who cannot join
- Clinical diagnosis of acute critical illness in the latest 1 year
- Have had weight fluctuation by more than 5%
- Eating disorders
- Neuropsychological disorders
- Allergy to corn or yeast
Trial locations and contacts
No sites are listed yet.
About this study
Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.
- Conditions
- Selenium Deficiency
- Being tested
- selenium supplementation, ordinary corn powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenium supplementationDietary supplement
administration of selenium-rich corn powder 20g/d offering selenium 100μg/d
ordinary corn powderDietary supplement
Also called low selenium
ordinary corn powder,20g/d(selenium contain <0.5ug/20g).
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Participants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period. Receives: Dietary Supplement: selenium supplementation; Dietary Supplement: ordinary corn powder |
| B | Placebo comparator | Participants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period. Receives: Dietary Supplement: selenium supplementation; Dietary Supplement: ordinary corn powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of thyroid function
comparison of thyroid function between administration of selenium supplementation and placebo
Measured: plasma sample will be collected at -1w/4w/8w/12w
Secondary outcomes (3)
comparison of serum selenium
comparison of serum selenium between administration of selenium supplementation and placebo
Measured: plasma sample will be collected at -1w/4w/8w/12w
comparison of erythrocyte glutathione peroxidase activity
comparison of erythrocyte glutathione peroxidase activity between administration of selenium supplementation and placebo
Measured: plasma sample will be collected at -1w/4w/8w/12w
comparison of serum deiodinase activity
comparison of serum deiodinase activity between administration of selenium supplementation and placebo
Measured: plasma sample will be collected at -1w/4w/8w/12w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 20 participants with selenium deficiency (confirmed in previous phase (ID: Liuyanping3)) will be recruited to receive selenium-rich corn powder (20g/d, offering selenium 100μg/d) and ordinary corn powder (20g/d, offering selenium \< 0.5μg/d ) in two different sequences (10 subjects each) with a four-week washout period.Plasma samples were obtained at different time points before and after administration of the selenium-rich corn powder and ordinary corn powder.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT03445078
- Sponsor's protocol ID
- Liuyanping4
- Status last verified
- May 2018
- First submitted
- 7 Feb 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Selenium Deficiency Has Effect on Thyroid Function
- ClinicalTrials.gov ID
- NCT03445078
- Acronym / sponsor ID
- Liuyanping4
- Conditions
- Selenium Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 26 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.
Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 20 participants with selenium deficiency (confirmed in previous phase (ID: Liuyanping3)) will be recruited to receive selenium-rich corn powder (20g/d, offering selenium 100μg/d) and ordinary corn powder (20g/d, offering selenium < 0.5μg/d ) in two different sequences (10 subjects each) with a four-week washout period.Plasma samples were obtained at different time points before and after administration of the selenium-rich corn powder and ordinary corn powder.
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: selenium supplementation, Dietary Supplement: ordinary corn powderParticipants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period. |
| B | Placebo comparator | Dietary Supplement: selenium supplementation, Dietary Supplement: ordinary corn powderParticipants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study
- Should have stable body weight in the latest 3 months;
- Should be not prescribed with thyroid hormone replacement therapy
- Should be without medical history of thyroid surgery or iodine radiotherapy
- Should have normal FT3, FT4 and TSH.
Key exclusion criteria (5 listed)
- Clinical diagnosis of acute critical illness in the latest 1 year
- Have had weight fluctuation by more than 5%
- 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 |
|---|---|---|
| selenium supplementationadministration of selenium-rich corn powder 20g/d offering selenium 100μg/d | Dietary supplement | A, B |
| ordinary corn powderAlso: low seleniumordinary corn powder,20g/d(selenium contain <0.5ug/20g). | Dietary supplement | A, B |
Primary outcome
comparison of thyroid function
Time frame: plasma sample will be collected at -1w/4w/8w/12w
comparison of thyroid function between administration of selenium supplementation and placebo
3 secondary outcomes
comparison of serum selenium
Time frame: plasma sample will be collected at -1w/4w/8w/12w
comparison of erythrocyte glutathione peroxidase activity
Time frame: plasma sample will be collected at -1w/4w/8w/12w
comparison of serum deiodinase activity
Time frame: plasma sample will be collected at -1w/4w/8w/12w
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing selenium supplementation and ordinary corn powder in people with Selenium Deficiency, run by Peking Union Medical College Hospital.
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 5 inclusion and 5 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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
comparison of thyroid function (time frame: plasma sample will be collected at -1w/4w/8w/12w). 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 31 May 2018.