Bone Turnover and Parenteral Nutrition

Bone Turnover Rate Disorder Clinical Trial

Official title:

Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618394
• Other study ID #: 29042015
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Iaso Maternity Hospital, Athens, Greece
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Bone Turnover Rate Disorder

Intervention

Dietary Supplement:
• MCT/?-3-PUFA
lipid emulsion
• Soybean Based
lipid emulsion

Locations

Country	Name	City	State
Greece	Panos Papandreou	Athens

Sponsors (3)

Lead Sponsor	Collaborator
Iaso Maternity Hospital, Athens, Greece	Harokopio University, National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in plasma calcium and osteocalcin levels	Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life	20 days
Secondary	change in plasma DHA, EPA levels	Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life	20 days
Secondary	cange in plasma OPG levels	Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life	20 days