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Bone Turnover and Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618394
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Harokopio University
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Panos Papandreou, Iaso Maternity Hospital, Athens, Greece

Study Description
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Brief Summary:
Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.

Condition or disease Intervention/treatment
Bone Turnover Rate Disorder Dietary Supplement: MCT/ω-3-PUFA Dietary Supplement: Soybean Based

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 Design
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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : July 1, 2018
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
plasma

Eligibility Criteria
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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Very Low Birth Weight preterm neonates with gestational age <32 weeks
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618394


Locations
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Greece
Panos Papandreou
Athens, Greece, 15123
Sponsors and Collaborators
Iaso Maternity Hospital, Athens, Greece
Harokopio University
National and Kapodistrian University of Athens
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Panos Papandreou, Clinical Pharmacist, PharmD, Iaso Maternity Hospital, Athens, Greece
ClinicalTrials.gov Identifier: NCT03618394    
Other Study ID Numbers: 29042015
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panos Papandreou, Iaso Maternity Hospital, Athens, Greece:
preterms
parenteral
lipid