B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants

This study has been completed.
Sponsor:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01201005
First received: September 12, 2010
Last updated: September 13, 2010
Last verified: September 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 26, 2014