Mild HyperhomocysteinemiaPhase 1NCT00877227
Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns
A Phase 1 study testing 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv) in people with Mild Hyperhomocysteinemia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. Read more about this study
- Who is it for?
- Ages Up to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Mild Hyperhomocysteinemia
- What is being tested?
- 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Nov 2003
- Phase
- Phase 1
- 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 Up to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- admitted at our NICU
Who cannot join
- midline defects
- Extracorporeal membrane oxygenation (ECMO) treatment
- blood transfusion
- overt renal failure
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical center Nijmegen
Nijmegen, 6500HB
About this study
Official title: Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.
Read the detailed description
The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.
We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.
- Conditions
- Mild Hyperhomocysteinemia
- Being tested
- 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)
- Keywords
- CVA, stroke, newborns, homocysteine, folinic acid
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)Drug
Also called folinic acid
Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns.
| Study group | Role | What they receive |
|---|---|---|
| folinic acid | Experimental | Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns Receives: Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv) |
| 2 | No intervention | control subjects admitted at the Neonatal Intensive Care Unit (NICU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowering total homocysteine concentrations
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJan 2003
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild HyperhomocysteinemiaStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Henk Blom, Dr, Study chair, Amsterdam UMC, location VUmcMarije Hogeveen, MD, Principal investigator, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877227
- Sponsor's protocol ID
- 0010-0237
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
- ClinicalTrials.gov ID
- NCT00877227
- Acronym / sponsor ID
- 0010-0237
- Conditions
- Mild Hyperhomocysteinemia
- Keywords
- CVA, stroke, newborns, homocysteine, folinic acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 7 Apr 2009 (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.
The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.
Detailed description
The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.
We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| folinic acid | Experimental | Drug: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns |
| 2 | No intervention | –control subjects admitted at the Neonatal Intensive Care Unit (NICU) |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- admitted at our NICU
Key exclusion criteria (4 listed)
- midline defects
- Extracorporeal membrane oxygenation (ECMO) treatment
- blood transfusion
- overt renal failure
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 |
|---|---|---|
| 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv)Also: folinic acidFolinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns. | Drug | folinic acid |
Primary outcome
lowering total homocysteine concentrations
Time frame: 2 weeks
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 6 May 2009.
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.
Henk Blom, Dr study chair
Amsterdam UMC, location VUmc
Marije Hogeveen, MD principal investigator
Radboud University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv) in people with Mild Hyperhomocysteinemia, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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 6 May 2009. 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 Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
lowering total homocysteine concentrations (time frame: 2 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 6 May 2009.