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Bone Turnover and Parenteral Nutrition

I

Iaso Maternity Hospital, Athens, Greece

Status

Completed

Conditions

Bone Turnover Rate Disorder

Treatments

Dietary Supplement: MCT/ω-3-PUFA
Dietary Supplement: Soybean Based

Study type

Observational

Funder types

Other

Identifiers

NCT03618394
29042015

Details and patient eligibility

About

Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.

Full description

Osteopenia is very common in premature infants, particularly in preterm infants born at extremely low birth weight This is probably related to inadequate calcium and phosphorus intake, which is considerably less than the accretion of these minerals during the last trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g. bronchopulmonary dysplasia [BPD]), chronic drug therapy (e.g. diuretics and systemic steroids), the need for total parenteral nutrition and prolonged immobility increase the risk of bone demineralization.

Total parenteral nutrition is associated with osteopenia in preterm infants. Insufficient calcium and phosphate are likely causes; aluminum contamination is another possible contributing factor as this adversely affects bone formation and mineralization.

The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at <33 wk gestation. Smof lipid emulsion has a high density of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and turnover.

Enrollment

66 patients

Sex

All

Ages

1 to 3 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • gestational age <32 weeks
  • birth weight <1500g (VLBW infants)
  • in need of Parenteral Nutrition support

Exclusion criteria

  • >32 weeks of gestation
  • chromosomal or other abnormalities
  • parenteral nutrition <80% of calorie/fluid needs
  • primary liver disease

Trial design

66 participants in 2 patient groups

Smoflipid
Description:
premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion
Treatment:
Dietary Supplement: MCT/ω-3-PUFA
Intralipid
Description:
premature neonates receiving Soybean Based lipid emulsion
Treatment:
Dietary Supplement: Soybean Based

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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