Vitamin B 12 DeficiencyNCT00479479
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
A study testing Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) in people with Vitamin B 12 Deficiency, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life. Read more about this study
- Who is it for?
- Ages 4 weeks to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2004to Dec 2006
- 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 4 weeks to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 weeks old infants
- The infant should be healthy and not have any serious malformations
- The mother should be healthy and not have any serious disorders or use any daily medications
- The mother should have an ordinary omnivorous diet
Who cannot join
- If there are evidence of serious infant disease during the study period, the infant should be excluded from the study
Trial locations and contacts
1 site in 1 country.
Norway1 site
Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital
Bergen, 5018
About this study
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.
The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
Read the detailed description
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. A metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature organ systems or cobalamin deficiency has not been clarified.
Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.
The purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
Six weeks old infants will be randomly assigned to receive either an intramuscular injection with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum, and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco will be completed.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
- Keywords
- cobalamin, methylmalonic acid, homocysteine, folate, newborns, infants, Deficiency Disease, Breastfeeding, Infant
- Medical subject headings
- Vitamin B 12 Deficiency, Deficiency Diseases, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)Drug
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
| Study group | Role | What they receive |
|---|---|---|
| Cobalamin | Experimental | An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway) Receives: Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA
Measured: Infant age 6 weeks - 4 months
Secondary outcomes (1)
Outcome is related to changes in growth parameters; weight, length, head circumference
Measured: Infant age: 6 weeks - 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startDec 2004
- Primary completionAug 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies 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
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
- Responsible party
- Sponsor
- Investigators
- Anne-Lise Bjørke Monsen, M.D., Ph.D., Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479479
- Sponsor's protocol ID
- 16941
- Status last verified
- Jul 2015
- First submitted
- 25 May 2007
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjorke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. doi: 10.1542/peds.108.3.624.
PubMed 11533328Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75. doi: 10.1373/clinchem.2003.019869.
PubMed 14633879Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. doi: 10.1007/978-1-4899-2575-6_14.
PubMed 7832046Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
PubMed 9930566Bjorke-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 18595990
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
- ClinicalTrials.gov ID
- NCT00479479
- Acronym / sponsor ID
- 16941
- Conditions
- Vitamin B 12 Deficiency
- Keywords
- cobalamin, methylmalonic acid, homocysteine, folate, newborns, infants, Deficiency Disease, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
- Study start
- Dec 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 May 2007 (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.
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.
The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
Detailed description
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. A metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature organ systems or cobalamin deficiency has not been clarified.
Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.
The purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
Six weeks old infants will be randomly assigned to receive either an intramuscular injection with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum, and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco will be completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cobalamin | Experimental | Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway) |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 4 weeks to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6 weeks old infants
- The infant should be healthy and not have any serious malformations
- The mother should be healthy and not have any serious disorders or use any daily medications
- The mother should have an ordinary omnivorous diet
Key exclusion criteria (1 listed)
- If there are evidence of serious infant disease during the study period, the infant should be excluded from the study
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 |
|---|---|---|
| Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway) | Drug | Cobalamin |
Primary outcome
Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA
Time frame: Infant age 6 weeks - 4 months
1 secondary outcome
Outcome is related to changes in growth parameters; weight, length, head circumference
Time frame: Infant age: 6 weeks - 4 months
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 21 Jul 2015.
- Background: PubMed 11533328Bjorke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. doi: 10.1542/peds.108.3.624.
- Background: PubMed 14633879Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75. doi: 10.1373/clinchem.2003.019869.
- Background: PubMed 7832046Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. doi: 10.1007/978-1-4899-2575-6_14.
- Background: PubMed 9930566Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
- Derived from this study: 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.
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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.
Anne-Lise Bjørke Monsen, M.D., Ph.D. principal investigator
Haukeland University Hospital
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 (Vitamin B12 Depot, Nycomed Pharma) in people with Vitamin B 12 Deficiency, 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 4 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 21 Jul 2015. 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. 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?
Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA (time frame: Infant age 6 weeks - 4 months). 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 NCT00479479, which also lists 5 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 21 Jul 2015.