Nutritional RequirementsLoDoSeNCT00803699
Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
A study testing selenium as L-selenomethionine in people with Nutritional Requirements, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Requirements
- What is being tested?
- selenium as L-selenomethionine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to swallow capsules
- body mass index less than 40
Who cannot join
- Pregnancy
- Chronic liver or kidney disease
- taking medication that might affect liver and/or kidney
- blood pressure 140/90 or higher
- already taking more than 50 micrograms of selenium
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202
About this study
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.
Read the detailed description
Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.
- Conditions
- Nutritional Requirements
- Being tested
- placebo, selenium as L-selenomethionine
- Keywords
- selenium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
daily placebo capsules for 12 months
selenium as L-selenomethionineDietary supplement
daily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsule contains no selenium Receives: Dietary Supplement: placebo |
| Selenium as L-selenomethionine | Active comparator | 50, 100, or 200 micrograms of selenium Receives: Dietary Supplement: selenium as L-selenomethionine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
Measured: Baseline, and after 3, 6, 9, and 12 months of supplementation
Secondary outcomes (1)
Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.
Measured: Baseline and after 12 months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional RequirementsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gerald F Combs, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803699
- Sponsor's protocol ID
- GFHNRC009
- Other IDs
- NCI Agreement#Y1-CN-2017-04
- Acronym
- LoDoSe
- Status last verified
- May 2018
- First submitted
- 3 Dec 2008
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. doi: 10.1097/MCO.0b013e3283139674.
PubMed 18827575
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
- ClinicalTrials.gov ID
- NCT00803699
- Acronym / sponsor ID
- LoDoSe / GFHNRC009
- Conditions
- Nutritional Requirements
- Keywords
- selenium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 5 Dec 2008 (estimated)
- 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.
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.
Detailed description
Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placeboCapsule contains no selenium |
| Selenium as L-selenomethionine | Active comparator | Dietary Supplement: selenium as L-selenomethionine50, 100, or 200 micrograms of selenium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- able to swallow capsules
- body mass index less than 40
Key exclusion criteria (5 listed)
- Pregnancy
- Chronic liver or kidney disease
- taking medication that might affect liver and/or kidney
- blood pressure 140/90 or higher
- already taking more than 50 micrograms of selenium
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 |
|---|---|---|
| placebodaily placebo capsules for 12 months | Dietary supplement | Placebo |
| selenium as L-selenomethioninedaily capsules of 50, 100, or 200 micrograms of L-selenomethionine for 12 months | Dietary supplement | Selenium as L-selenomethionine |
Primary outcome
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
Time frame: Baseline, and after 3, 6, 9, and 12 months of supplementation
1 secondary outcome
Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.
Time frame: Baseline and after 12 months of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Background: PubMed 18827575Jackson MI, Combs GF Jr. Selenium and anticarcinogenesis: underlying mechanisms. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):718-26. doi: 10.1097/MCO.0b013e3283139674.
Related trials for Nutritional Requirements
Recruiting
Adiposity and Iron Requirements in Pregnancy
Iron Deficiency Anemia of Pregnancy
Recruiting
Dietary Iron Requirements
Iron Absorption
RecruitingObservational study
Optimizing Nutrition and Milk (Opti-NuM) Project
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
RecruitingObservational study
Protein Requirements After Bariatric Surgery
Obesity and Overweight, Bariatric Surgery (Gastric Bypass)
Active, not recruitingObservational study
Extreme Morphology and Metabolic Health
Skeletal Dysplasia
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.
Gerald F Combs, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selenium as L-selenomethionine in people with Nutritional Requirements, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 29 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations (time frame: Baseline, and after 3, 6, 9, and 12 months of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803699, which also lists 1 linked publication.
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 29 May 2018.