End Stage Renal DiseaseNCT02011191
Biotin Deficiency and Restless Legs Syndrome
A study testing Biotin Supplementation and Sugar Pill in people with End Stage Renal Disease and Restless Legs Syndrome, run by Heidi Moretti, MS, RD.
Trial summary
Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease, Restless Legs Syndrome
- What is being tested?
- Biotin Supplementation and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months.
Who cannot join
- History of consumption of more than 300 micrograms daily of biotin
- Oral contraceptive therapy containing high amounts of estrogen because studies in rats provide evidence that high doses of steroid hormones reduce biotin status {Wang, 1997 #1634}
- Women of childbearing age because of concern that biotin deficiency may be teratogenic {Mock, 2009 #2568}.
About this study
Official title: Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial
Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.
Read the detailed description
Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.
- Conditions
- End Stage Renal Disease, Restless Legs Syndrome
- Being tested
- Biotin Supplementation, Sugar Pill
- Keywords
- Biotin, Restless, Kidney, Dialysis, Renal
- Medical subject headings
- Kidney Failure, Chronic, Restless Legs Syndrome, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotin SupplementationDietary supplement
Also called Biotin, Hillestad Pharmeceuticals
10,000 micrograms biotin supplement daily for 8 weeks
Sugar PillDietary supplement
Also called Hillestad Pharmeceuticals
Identical sugar pill, identical bottle as the biotin supplementation group
| Study group | Role | What they receive |
|---|---|---|
| Biotin | Active comparator | 10,000 micrograms biotin daily for 8 weeks Receives: Dietary Supplement: Biotin Supplementation |
| Sugar pill | Placebo comparator | Not described Receives: Dietary Supplement: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biotin Status of Dialysis Patients
Biotin status is measured using Propionyl CoA carboxylase and Propionyl CoA carboxylase activation coefficients that are from isolated lymphocyte samples. This is a measurement that is independent of kidney function.
Measured: Measurement at baseline and after 8 weeks of treatment
Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment
The RLS is measured using the International Restless Legs Syndrome Scale, a validated tool for assessing severity of RLS in patient who have been diagnosed with RLS.
Measured: Baseline RLS score measurement and measurement after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidi Moretti, MS, RD
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Patrick Hospital, University of Arkansas
- Responsible party
- Sponsor-investigator, Heidi Moretti, MS, RD, Saint Patrick Hospital
- Investigators
- John Lakatua, MD, Principal investigator, Saint Patrick Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011191
- Sponsor's protocol ID
- NIH DK 36823-28
- Status last verified
- Dec 2013
- First submitted
- 3 Jan 2012
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biotin Deficiency and Restless Legs Syndrome: Evidence for a Causal Relationship From Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02011191
- Acronym / sponsor ID
- NIH DK 36823-28
- Conditions
- End Stage Renal Disease, Restless Legs Syndrome
- Keywords
- Biotin, Restless, Kidney, Dialysis, Renal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Heidi Moretti, MS, RDUniversity, hospital or other
- Collaborators
- Saint Patrick Hospital, University of Arkansas
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Dec 2013 (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.
Restless Leg Syndrome (RLS) is a common neuropathic disorder in patients with end stage renal disease (ESRD). Study Design: Because micronutrient depletion has been associated with RLS in ESRD and because the vitamin biotin is dialyzable, the investigators examined the relationship between biotin status and RLS in ESRD. Objectives: To assess the prevalence of biotin deficiency in those with and without RLS (Study 1) and to determine the effect of biotin supplementation on RLS symptoms (Study 2) in patients receiving chronic dialysis due to ESRD.
Detailed description
Setting and Participants: ESRD patients receiving chronic dialysis as outpatients at Saint Patrick Hospital in Missoula, Montana.
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 |
|---|---|---|
| Biotin | Active comparator | Dietary Supplement: Biotin Supplementation10,000 micrograms biotin daily for 8 weeks |
| Sugar pill | Placebo comparator | Dietary Supplement: Sugar Pill |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD requiring hemodialysis or peritoneal dialysis therapy for a duration of at least 3 months.
Key exclusion criteria (3 listed)
- History of consumption of more than 300 micrograms daily of biotin
- Oral contraceptive therapy containing high amounts of estrogen because studies in rats provide evidence that high doses of steroid hormones reduce biotin status {Wang, 1997 #1634}
- Women of childbearing age because of concern that biotin deficiency may be teratogenic {Mock, 2009 #2568}.
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 |
|---|---|---|
| Biotin SupplementationAlso: Biotin, Hillestad Pharmeceuticals10,000 micrograms biotin supplement daily for 8 weeks | Dietary supplement | Biotin |
| Sugar PillAlso: Hillestad PharmeceuticalsIdentical sugar pill, identical bottle as the biotin supplementation group | Dietary supplement | Sugar pill |
Primary outcome
Biotin Status of Dialysis Patients
Time frame: Measurement at baseline and after 8 weeks of treatment
Biotin status is measured using Propionyl CoA carboxylase and Propionyl CoA carboxylase activation coefficients that are from isolated lymphocyte samples. This is a measurement that is independent of kidney function.
Change in Restless Legs Syndrome (RLS) symptoms after Biotin treatment
Time frame: Baseline RLS score measurement and measurement after 8 weeks of treatment
The RLS is measured using the International Restless Legs Syndrome Scale, a validated tool for assessing severity of RLS in patient who have been diagnosed with RLS.
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 13 Dec 2013.
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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.
John Lakatua, MD principal investigator
Saint Patrick Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Biotin Supplementation and Sugar Pill in people with End Stage Renal Disease and Restless Legs Syndrome, run by Heidi Moretti, MS, RD.
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 1 inclusion and 3 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 13 Dec 2013. 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?
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?
Biotin Status of Dialysis Patients (time frame: Measurement at baseline and after 8 weeks of treatment). The study lists 2 primary outcomes in all. 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 13 Dec 2013.