Biochemical Cobalamin StatusNCT01201005
B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants
A study testing Hydroxycobalamin in people with Biochemical Cobalamin Status and Motor Neurodevelopment, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Biochemical Cobalamin Status, Motor Neurodevelopment
- What is being tested?
- Hydroxycobalamin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2009to Aug 2010
- 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 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birthweight < 3000 grams
- Age 6 months (+/- 0.5 months)
- Plasma total homocysteine > 6.5 umol/L
Who cannot join
- Plasma total homocysteine < 6.5 umol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.
Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.
- Being tested
- Hydroxycobalamin, Sham injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxycobalaminDietary supplement
Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
Sham injectionDietary supplement
needle injection without any substance given
| Study group | Role | What they receive |
|---|---|---|
| Hydroxycobalamin | Active comparator | Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma) is given as a singel intramuscular injection.
The syringe is covered so it is impossible to see whether it contains any substance Receives: Dietary Supplement: Hydroxycobalamin |
| needle injection | Sham comparator | The controls receive an intramuscular "injection": which is merely an introduction of the needle into the muscle whithout any injection. The syringe is covered so it is not possible to see whether the syringe contains any substance Receives: Dietary Supplement: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in biochemical status and neurodevelopment
Bloodsamples for analysis of B vitamin status are drawn before intervention and after 4 weeks Neurological evaluation (AIMS test) of the infants is done before intervention and after 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Maternal evaluation of changes in infant behaviour/development
Maternal evaluation of changes in infant behaviour will be tested by using a maternal questionnaire, Ages and Stages (ASQ), a highly rated child screening and monitoring system, before and after intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biochemical Cobalamin StatusStudies of the same condition, open and under way.
- More trials run by Haukeland University 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201005
- Sponsor's protocol ID
- REK-Vest 104.08
- Status last verified
- Sep 2010
- First submitted
- 12 Sep 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.
PubMed 18595990Torsvik IK, Ueland PM, Markestad T, Midttun O, Bjorke Monsen AL. Motor development related to duration of exclusive breastfeeding, B vitamin status and B12 supplementation in infants with a birth weight between 2000-3000 g, results from a randomized intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.
PubMed 26678525Torsvik IK, Markestad T, Ueland PM, Nilsen RM, Midttun O, Bjorke Monsen AL. Evaluating iron status and the risk of anemia in young infants using erythrocyte parameters. Pediatr Res. 2013 Feb;73(2):214-20. doi: 10.1038/pr.2012.162. Epub 2012 Nov 20.
PubMed 23168578
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
- ClinicalTrials.gov ID
- NCT01201005
- Acronym / sponsor ID
- REK-Vest 104.08
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Sep 2010 (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.
Premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. During the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific B vitamin deficiencies. In this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. At 6 months infants with biochemical signs of impaired cobalamin status (i.e.: tHcy > 97.5 percentile for cobalamin treated infants, i.e.: tHcy>6.5 µM/L) will be randomised to cobalamin treatment or placebo. At 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment.
Study hypothesis: Cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxycobalamin | Active comparator | Dietary Supplement: HydroxycobalaminHydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma) is given as a singel intramuscular injection. The syringe is covered so it is impossible to see whether it contains any substance |
| needle injection | Sham comparator | Dietary Supplement: Sham injectionThe controls receive an intramuscular "injection": which is merely an introduction of the needle into the muscle whithout any injection. The syringe is covered so it is not possible to see whether the syringe contains any substance |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Birthweight < 3000 grams
- Age 6 months (+/- 0.5 months)
- Plasma total homocysteine > 6.5 umol/L
Key exclusion criteria (1 listed)
- Plasma total homocysteine < 6.5 umol/L
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 |
|---|---|---|
| HydroxycobalaminHydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection | Dietary supplement | Hydroxycobalamin |
| Sham injectionneedle injection without any substance given | Dietary supplement | needle injection |
Primary outcome
Changes in biochemical status and neurodevelopment
Time frame: 4 weeks
Bloodsamples for analysis of B vitamin status are drawn before intervention and after 4 weeks Neurological evaluation (AIMS test) of the infants is done before intervention and after 4 weeks
1 secondary outcome
Maternal evaluation of changes in infant behaviour/development
Time frame: 4 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 14 Sep 2010.
- Background: PubMed 18595990Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.
- Derived from this study: PubMed 26678525Torsvik IK, Ueland PM, Markestad T, Midttun O, Bjorke Monsen AL. Motor development related to duration of exclusive breastfeeding, B vitamin status and B12 supplementation in infants with a birth weight between 2000-3000 g, results from a randomized intervention trial. BMC Pediatr. 2015 Dec 18;15:218. doi: 10.1186/s12887-015-0533-2.
- Derived from this study: PubMed 23168578Torsvik IK, Markestad T, Ueland PM, Nilsen RM, Midttun O, Bjorke Monsen AL. Evaluating iron status and the risk of anemia in young infants using erythrocyte parameters. Pediatr Res. 2013 Feb;73(2):214-20. doi: 10.1038/pr.2012.162. Epub 2012 Nov 20.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxycobalamin in people with Biochemical Cobalamin Status and Motor Neurodevelopment, run by Haukeland University Hospital at 1 site in Norway.
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 3 inclusion and 1 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 14 Sep 2010. 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 Norway. 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?
Changes in biochemical status and neurodevelopment (time frame: 4 weeks). 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 NCT01201005, which also lists 3 linked publications.
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 14 Sep 2010.