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Completed

NCT Number: NCT03618394

Bone Turnover and Parenteral Nutrition

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

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Key information

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Panos Papandreou

Athens, 15123, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MCT/ω-3-PUFA

Dietary Supplement

lipid emulsion

Soybean Based

Dietary Supplement

lipid emulsion

Primary outcomes

  1. change in plasma calcium and osteocalcin levels

    Time frame: 20 days

    Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

Secondary outcomes

  1. change in plasma DHA, EPA levels

    Time frame: 20 days

    Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

  2. cange in plasma OPG levels

    Time frame: 20 days

    Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

Sponsors and collaborators

Lead sponsor

Iaso Maternity Hospital, Athens, Greece

Other

Collaborators

  • Harokopio University
  • National and Kapodistrian University of Athens

Registry information

Official study title

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2018
Registry last updated
Aug 7, 2018

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.

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