Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-14 @ 3:08 AM
Study NCT ID:
NCT03618394
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2018-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Turnover and Parenteral Nutrition
Sponsor:
Iaso Maternity Hospital, Athens, Greece
Organization:
Study Overview
Official Title:
Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: