Vitamin B 12 DeficiencyNCT00710138
Cobalamin Status in Young Children With Developmental Delay
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
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding… Read more about this study
- Who is it for?
- Ages Up to 8 months
- 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?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2008to 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 Up to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children below 8 months of age
- Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms
Who cannot join
- Children with syndromic disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Pediatrics, Haukeland University Hospital
Bergen, 5021
About this study
Official title: Cobalamin Status in Young Children With Developmental Delay and Regression
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.
In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
- Keywords
- Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Neurodevelopment, Neurological symptoms
- Medical subject headings
- Vitamin B 12 Deficiency, Neurologic Manifestations
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)Dietary supplement
Also called Vitamin B12, Cobalamin, B vitamins
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) given as a single intramuscular injection. The syringe is covered so it is impossible to see whether or not it contains any substance. Receives: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) |
| 2 | Sham comparator | The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance. Receives: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters
Measured: Reevalutation after 4 weeks
Secondary outcomes (1)
Maternal evaluation of infant behaviour
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJun 2008
- 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 (7)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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
- Investigators
- Anne-Lise Bjørke Monsen, M.D., Ph.D., Principal investigator, Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, NorwayPer Magne Ueland, M.D., Ph.D., Study director, Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710138
- Sponsor's protocol ID
- 19072
- Status last verified
- Aug 2010
- First submitted
- 2 Jul 2008
- Last updated
- 16 Aug 2010
- 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 11533328Graham SM, Arvela OM, Wise GA. Long-term neurologic consequences of nutritional vitamin B12 deficiency in infants. J Pediatr. 1992 Nov;121(5 Pt 1):710-4. doi: 10.1016/s0022-3476(05)81897-9.
PubMed 1432418Casella EB, Valente M, de Navarro JM, Kok F. Vitamin B12 deficiency in infancy as a cause of developmental regression. Brain Dev. 2005 Dec;27(8):592-4. doi: 10.1016/j.braindev.2005.02.005.
PubMed 16310594Grattan-Smith PJ, Wilcken B, Procopis PG, Wise GA. The neurological syndrome of infantile cobalamin deficiency: developmental regression and involuntary movements. Mov Disord. 1997 Jan;12(1):39-46. doi: 10.1002/mds.870120108.
PubMed 8990052Rosenblatt 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 18595990Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.
PubMed 24025626
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobalamin Status in Young Children With Developmental Delay and Regression
- ClinicalTrials.gov ID
- NCT00710138
- Acronym / sponsor ID
- 19072
- Conditions
- Vitamin B 12 Deficiency
- Keywords
- Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Neurodevelopment, Neurological symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- 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
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Jul 2008 (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.
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.
In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) given as a single intramuscular injection. The syringe is covered so it is impossible to see whether or not it contains any substance. |
| 2 | Sham comparator | Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance. |
Who may qualify
- Ages
- Up to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children below 8 months of age
- Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms
Key exclusion criteria (1 listed)
- Children with syndromic disease
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)Also: Vitamin B12, Cobalamin, B vitamins400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection | Dietary supplement | 1, 2 |
Primary outcome
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters
Time frame: Reevalutation after 4 weeks
1 secondary outcome
Maternal evaluation of infant behaviour
Time frame: After 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 16 Aug 2010.
- 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 1432418Graham SM, Arvela OM, Wise GA. Long-term neurologic consequences of nutritional vitamin B12 deficiency in infants. J Pediatr. 1992 Nov;121(5 Pt 1):710-4. doi: 10.1016/s0022-3476(05)81897-9.
- Background: PubMed 16310594Casella EB, Valente M, de Navarro JM, Kok F. Vitamin B12 deficiency in infancy as a cause of developmental regression. Brain Dev. 2005 Dec;27(8):592-4. doi: 10.1016/j.braindev.2005.02.005.
- Background: PubMed 8990052Grattan-Smith PJ, Wilcken B, Procopis PG, Wise GA. The neurological syndrome of infantile cobalamin deficiency: developmental regression and involuntary movements. Mov Disord. 1997 Jan;12(1):39-46. doi: 10.1002/mds.870120108.
- Background: PubMed 9930566Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
- 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 24025626Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.
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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
Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
Per Magne Ueland, M.D., Ph.D. study director
Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
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 2 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 16 Aug 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?
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters (time frame: Reevalutation after 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 NCT00710138, which also lists 7 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 16 Aug 2010.