B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants - Full Text View

Purpose

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.

Condition	Intervention
Biochemical Cobalamin Status Motor Neurodevelopment	Dietary Supplement: Hydroxycobalamin Dietary Supplement: Sham injection

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins

Drug Information available for: Cyanocobalamin Vitamin B Complex Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Changes in biochemical status and neurodevelopment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Maternal evaluation of changes in infant behaviour/development [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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

Enrollment:	80
Study Start Date:	July 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Hydroxycobalamin 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	Dietary Supplement: Hydroxycobalamin Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
Sham Comparator: needle injection 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	Dietary Supplement: Sham injection needle injection without any substance given

Eligibility

Ages Eligible for Study:	5 Months to 7 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Birthweight < 3000 grams
Age 6 months (+/- 0.5 months)
Plasma total homocysteine > 6.5 umol/L

Exclusion Criteria:

Plasma total homocysteine < 6.5 umol/L

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201005

Locations

Norway
Haukeland University Hospital
Bergen, Norway, 5021

Sponsors and Collaborators

Haukeland University Hospital

More Information

Publications:

Bjørke-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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Torsvik IK, Markestad T, Ueland PM, Nilsen RM, Midttun O, Bjørke 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.

Responsible Party:	Anne-Lise Bjørke Monsen, Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT01201005 History of Changes
Other Study ID Numbers:	REK-Vest 104.08
Study First Received:	September 12, 2010
Last Updated:	September 13, 2010
Health Authority:	Norway: Ethics Committee

Additional relevant MeSH terms:

Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013