Bone Turnover and Parenteral Nutrition
- Conditions
- Bone Turnover Rate Disorder
- Interventions
- Dietary Supplement: MCT/ω-3-PUFADietary Supplement: Soybean Based
- Registration Number
- NCT03618394
- Lead Sponsor
- Iaso Maternity Hospital, Athens, Greece
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- gestational age <32 weeks
- birth weight <1500g (VLBW infants)
- in need of Parenteral Nutrition support
- >32 weeks of gestation
- chromosomal or other abnormalities
- parenteral nutrition <80% of calorie/fluid needs
- primary liver disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Smoflipid MCT/ω-3-PUFA premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion Intralipid Soybean Based premature neonates receiving Soybean Based lipid emulsion
- Primary Outcome Measures
Name Time Method change in plasma calcium and osteocalcin levels 20 days Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
- Secondary Outcome Measures
Name Time Method cange in plasma OPG levels 20 days Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
change in plasma DHA, EPA levels 20 days Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Trial Locations
- Locations (1)
Panos Papandreou
🇬🇷Athens, Greece