Parkinson's DiseaseHPPDNCT02422992
Haptoglobin and Iron in Parkinson's Disease
An observational study of Parkinson's Disease, run by Bastyr University at 3 sites in United States.
Trial summary
This is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD predisposition. Read more about this study
- Who is it for?
- Ages 35 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 342 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2013to Jun 2016
- 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 35 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's disease patients will be included in the study if they received a diagnosis of Parkinson's disease that meets the United Kingdom Brain Bank (UKBB) clinical criteria of Parkinson's disease diagnosis. Control participants will be included in the study if free of neurodegenerative diseases. A subset of the study participants (60 total) receive Magnetic Resonance Imaging to estimate brain iron
Who may be able to join
- Diagnosis of Parkinson's disease (UKBB clinical criteria).
- Exclusion criteria for the Parkinson's disease patients, for the blood draw and epidemiology visit:
- Presence of other neurodegenerative diseases, apart for Parkinson's disease
- two or more family members with Parkinson's disease
- presence of active cancer under treatment
- HIV sero-positivity, Hepatitis B, C, of A sero-positivity
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- rheumatoid arthritis
- recent blood donation (less than three months before the visit).
- fever at the time of the visit
Who cannot join
- presence of a neurodegenerative disease,
- presence of active cancer under treatment,
- HIV sero-positivity, Hepatitis B, C, of A sero-positivity
- rheumatoid arthritis
- recent blood donation (less than three months before the visit).
- fever at the time of the visit
Show all 15Show fewer
- presence in the body of a ferro-magnetic metallic foreign object such as, but not limited to:
- a cardiac pacemaker
- aneurism clip
- neuro-stimulator
- surgical clip
- artificial limb or joint
- orthopedic items, such as screws, nails, pins, rods,
- any metallic foreign body from a previous injury, bullets, shrapnels, metal slivers.
- exclusion criteria for MRI is also the presence of claustrophobia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bastyr University Research Institute
Kenmore, Washington, 98028
University of California
San Diego, California, 92093
University of Washington
Seattle, Washington, 98195
About this study
Official title: Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease
This is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD predisposition.
Read the detailed description
A total of 342 participants, 100 PD patients and 242 age- and gender matched controls, were included in the study. All study participants were seen for one study visit in the morning at one of two Bastyr University Clinics in the Seattle area. Study participants were fasting at the time of the visit. During the study visit, participants donated a blood sample for the blood tests and complete an epidemiology questionnaire.
A subset of 51 of the study participant who were seen for the visit at Bastyr University, underwent brain scan and Magnetic Resonance Imaging (MRI), at the University of Washington Department of Radiology. The MRI part of the study aims at estimating brain iron levels.
- Conditions
- Parkinson's Disease
- Keywords
- Iron metabolism, MRI, risk factors, haptoglobin phenotype
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD | 100 PD patients were patients diagnosed with Parkinson's disease | |
| Controls | 242 Controls were subjects free of neurodegenerative diseases, matched by age and gender to the PD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron metabolism differences between PD patients and controls
Iron metabolism will be measured by testing for serum iron and iron-binding proteins, and by estimating brain iron by MRI. Serum iron parameters that will be measured include total serum iron, iron-binding proteins such as transferrin and ferritin, and tests related to iron metabolism: transferrin % saturation, unsaturated iron binding capacity, soluble transferrin receptor, complete blood count, hemoglobin, uric acid, haptoglobin, haptoglobin phenotype. Differences in serum iron parameters, and brain iron levels, between PD patients and controls will be calculated.
Measured: Up to 7 years
Secondary outcomes (1)
Environmental factors affecting PD risk and gene-environment interactions
Questionnaire data will be analyzed to identify risk factors for PD by comparing lifestyle and dietary patterns from questionnaire between PD cases and controls. Interaction between haptoglobin phenotype and tobacco smoking on PD risk will be calculated, as well as interaction between haptoglobin phenotype and environmental factors such as tobacco smoking and diet on serum iron and brain iron levels.
Measured: recruitment until January 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
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 Parkinson's 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bastyr University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Paola Costa-Mallen, PhD, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422992
- Sponsor's protocol ID
- 12A-1330
- Acronym
- HPPD
- Status last verified
- Nov 2016
- First submitted
- 15 Apr 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Costa-Mallen P, Checkoway H, Zabeti A, Edenfield MJ, Swanson PD, Longstreth WT Jr, Franklin GM, Smith-Weller T, Sadrzadeh SM. The functional polymorphism of the hemoglobin-binding protein haptoglobin influences susceptibility to idiopathic Parkinson's disease. Am J Med Genet B Neuropsychiatr Genet. 2008 Mar 5;147B(2):216-22. doi: 10.1002/ajmg.b.30593.
PubMed 17918239
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02422992
- Acronym / sponsor ID
- HPPD / 12A-1330
- Conditions
- Parkinson's Disease
- Keywords
- Iron metabolism, MRI, risk factors, haptoglobin phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Bastyr UniversityUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Apr 2015 (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.
This is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD predisposition.
Detailed description
A total of 342 participants, 100 PD patients and 242 age- and gender matched controls, were included in the study. All study participants were seen for one study visit in the morning at one of two Bastyr University Clinics in the Seattle area. Study participants were fasting at the time of the visit. During the study visit, participants donated a blood sample for the blood tests and complete an epidemiology questionnaire.
A subset of 51 of the study participant who were seen for the visit at Bastyr University, underwent brain scan and Magnetic Resonance Imaging (MRI), at the University of Washington Department of Radiology. The MRI part of the study aims at estimating brain iron levels.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD | – | –100 PD patients were patients diagnosed with Parkinson's disease |
| Controls | – | –242 Controls were subjects free of neurodegenerative diseases, matched by age and gender to the PD patients |
Who may qualify
- Ages
- 35 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients will be included in the study if they received a diagnosis of Parkinson's disease that meets the United Kingdom Brain Bank (UKBB) clinical criteria of Parkinson's disease diagnosis. Control participants will be included in the study if free of neurodegenerative diseases. A subset of the study participants (60 total) receive Magnetic Resonance Imaging to estimate brain iron
Key inclusion criteria (9 listed)
- Diagnosis of Parkinson's disease (UKBB clinical criteria).
- Exclusion criteria for the Parkinson's disease patients, for the blood draw and epidemiology visit:
- Presence of other neurodegenerative diseases, apart for Parkinson's disease
- two or more family members with Parkinson's disease
- presence of active cancer under treatment
Key exclusion criteria (15 listed)
- presence of a neurodegenerative disease,
- presence of active cancer under treatment,
- HIV sero-positivity, Hepatitis B, C, of A sero-positivity
- rheumatoid arthritis
- recent blood donation (less than three months before the visit).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Iron metabolism differences between PD patients and controls
Time frame: Up to 7 years
Iron metabolism will be measured by testing for serum iron and iron-binding proteins, and by estimating brain iron by MRI. Serum iron parameters that will be measured include total serum iron, iron-binding proteins such as transferrin and ferritin, and tests related to iron metabolism: transferrin % saturation, unsaturated iron binding capacity, soluble transferrin receptor, complete blood count, hemoglobin, uric acid, haptoglobin, haptoglobin phenotype. Differences in serum iron parameters, and brain iron levels, between PD patients and controls will be calculated.
1 secondary outcome
Environmental factors affecting PD risk and gene-environment interactions
Time frame: recruitment until January 2016
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 Nov 2016.
- Background: PubMed 17918239Costa-Mallen P, Checkoway H, Zabeti A, Edenfield MJ, Swanson PD, Longstreth WT Jr, Franklin GM, Smith-Weller T, Sadrzadeh SM. The functional polymorphism of the hemoglobin-binding protein haptoglobin influences susceptibility to idiopathic Parkinson's disease. Am J Med Genet B Neuropsychiatr Genet. 2008 Mar 5;147B(2):216-22. doi: 10.1002/ajmg.b.30593.
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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.
Paola Costa-Mallen, PhD principal investigator
Bastyr University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Bastyr University at 3 sites 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 9 inclusion and 15 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Iron metabolism differences between PD patients and controls (time frame: Up to 7 years). 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 NCT02422992, 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 Nov 2016.