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Completed

NCT Number: NCT01201005

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

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.

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Key information

Conditions

Biochemical Cobalamin Status Motor Neurodevelopment

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxycobalamin

Dietary Supplement

Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection

Sham injection

Dietary Supplement

needle injection without any substance given

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

B VITAMIN STATUS IN PREMATURE AND SMALL FOR GESTATIONAL AGE INFANTS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2010
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.