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

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ClinicalTrials.gov Identifier: NCT01201005
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Haukeland University Hospital

Brief 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. 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 or disease Intervention/treatment Phase
Biochemical Cobalamin Status Motor Neurodevelopment Dietary Supplement: Hydroxycobalamin Dietary Supplement: Sham injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS
Study Start Date : July 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Maternal evaluation of changes in infant behaviour/development [ Time Frame: 4 weeks ]
    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



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Ages Eligible for Study:   5 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201005


Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital