Bone Turnover and Parenteral Nutrition

August 4, 2018 updated by: Panos Papandreou, Iaso Maternity Hospital, Athens, Greece

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 15123
        • Panos Papandreou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Very Low Birth Weight preterm neonates with gestational age <32 weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smoflipid
premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion
Dietary supplement: MCT/ω-3-PUFA
lipid emulsion
Intralipid
premature neonates receiving Soybean Based lipid emulsion
Dietary supplement: Soybean Based
lipid emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 days
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
20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iaso Maternity Hospital, Athens, Greece

Collaborators

National and Kapodistrian University of Athens
Harokopio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

July 25, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (ACTUAL)

August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 4, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29042015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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