Skip to content

Bone Turnover and Parenteral Nutrition

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03618394
Enrollment
66
Registered
2018-08-07
Start date
2015-04-01
Completion date
2018-07-01
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Turnover Rate Disorder

Keywords

preterms, parenteral, lipid

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTMCT/ω-3-PUFA

lipid emulsion

DIETARY_SUPPLEMENTSoybean Based

lipid emulsion

Sponsors

Harokopio University
CollaboratorOTHER
National and Kapodistrian University of Athens
CollaboratorOTHER
Iaso Maternity Hospital, Athens, Greece
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in plasma calcium and osteocalcin levels20 daysBlood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

Secondary

MeasureTime frameDescription
change in plasma DHA, EPA levels20 daysBlood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
cange in plasma OPG levels20 daysBlood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026