Bone Turnover Rate DisorderNCT03618394
Bone Turnover and Parenteral Nutrition
An observational study of Bone Turnover Rate Disorder, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
Trial summary
Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Bone Turnover Rate Disorder
- What is being tested?
- MCT/ω-3-PUFA and Soybean Based
- How many people
- 66 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2015to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Very Low Birth Weight preterm neonates with gestational age <32 weeks
Who may be able to join
- gestational age <32 weeks
- birth weight <1500g (VLBW infants)
- in need of Parenteral Nutrition support
Who cannot join
- >32 weeks of gestation
- chromosomal or other abnormalities
- parenteral nutrition <80% of calorie/fluid needs
- primary liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Turnover Rate Disorder
- Being tested
- MCT/ω-3-PUFA, Soybean Based
- Keywords
- preterms, parenteral, lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT/ω-3-PUFADietary supplement
lipid emulsion
Soybean BasedDietary supplement
lipid emulsion
| Study group | Role | What they receive |
|---|---|---|
| Smoflipid | premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion Receives: Dietary Supplement: MCT/ω-3-PUFA | |
| Intralipid | premature neonates receiving Soybean Based lipid emulsion Receives: Dietary Supplement: Soybean Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in plasma calcium and osteocalcin levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Measured: 20 days
Secondary outcomes (2)
change in plasma DHA, EPA levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Measured: 20 days
cange in plasma OPG levels
Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Apr 2015
- Primary completion1 Apr 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Turnover Rate DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iaso Maternity Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University, National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Panos Papandreou, Iaso Maternity Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618394
- Sponsor's protocol ID
- 29042015
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens
- ClinicalTrials.gov ID
- NCT03618394
- Acronym / sponsor ID
- 29042015
- Conditions
- Bone Turnover Rate Disorder
- Keywords
- preterms, parenteral, lipid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Iaso Maternity Hospital, Athens, GreeceUniversity, hospital or other
- Collaborators
- Harokopio University, National and Kapodistrian University of Athens
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoflipid | – | Dietary Supplement: MCT/ω-3-PUFApremature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion |
| Intralipid | – | Dietary Supplement: Soybean Basedpremature neonates receiving Soybean Based lipid emulsion |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very Low Birth Weight preterm neonates with gestational age <32 weeks
Key inclusion criteria (3 listed)
- gestational age <32 weeks
- birth weight <1500g (VLBW infants)
- in need of Parenteral Nutrition support
Key exclusion criteria (4 listed)
- >32 weeks of gestation
- chromosomal or other abnormalities
- parenteral nutrition <80% of calorie/fluid needs
- primary liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCT/ω-3-PUFAlipid emulsion | Dietary supplement | Smoflipid |
| Soybean Basedlipid emulsion | Dietary supplement | Intralipid |
Primary outcome
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
2 secondary outcomes
change in plasma DHA, EPA levels
Time frame: 20 days
cange in plasma OPG levels
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Turnover Rate Disorder, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in plasma calcium and osteocalcin levels (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.