Lipid ProfileNCT05242107
Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction
A study testing Omega-3 supplement group and Full feeding without receiving any supplementation group in people with Lipid Profile and Neonates, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR) Read more about this study
- Who is it for?
- Ages 1 day to 4 weeks
- Conditions the study is for
- Lipid Profile, Neonates, Intrauterine Growth Restriction
- What is being tested?
- Omega-3 supplement group and Full feeding without receiving any supplementation group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 10 Jan 2022
- Phase
- Interventional
- 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 4 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any full-term Intrauterine growth restriction (IUGR) neonate
Who cannot join
- Preterm neonates
- Who died before feeding was established
- Multiple congenital anomalies including GIT anomalies
- Congenital infection
- Cholestasis
- Infant of diabetic mother (IDM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction
The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)
Read the detailed description
Intrauterine growth restriction is a major cause of perinatal mortality and morbidity .
It is noted to affect approximately 5-15 % of pregnant women. Egypt has one of the highest incidences of Intrauterine Growth Restriction. The incidence of IUGR varies among countries, populations, races and increases with decreasing gestational age. 14 to 20 million infants have been affected with Intrauterine Growth Restriction cases in the developing countries annually.
A complex and dynamic interaction of maternal, placental and fetal environment is involved in ensuring normal fetal growth. An imbalance or lack of coordination in this complex system may lead to Intrauterine Growth Restriction. Intrauterine Growth Restriction( IUGR) results in significant perinatal and long-term complications, including increased neonatal mortality and morbidity and higher risk for developing metabolic syndrome later in life.
Physiological differences have been noted in growth restricted infants. Intrauterine amino acid disturbances similar to biochemical changes seen in postnatal protein deprived states have been detected. Protein metabolism defect and altered lipid metabolism also have been described.
Undernourishment in utero appears to be associated with persisting changes in the metabolic functions. Birth weight influences the lipoprotein profile and cholesteryl ester transfer protein, which promotes a proatherogenic lipoprotein profile in plasma by determining chemical, physical and biological properties of the respective lipoprotein particle in neonates.
Recent research suggests that several of major disease of later life, including coronary heart disease, hypertension \& type II diabetes originate in impaired intrauterine growth and development. These diseases may be consequence of programming whereby a stimulus or insult at a critical, sensitive period of early life has a permanent effect on structure, physiology and metabolism.
- Conditions
- Lipid Profile, Neonates, Intrauterine Growth Restriction
- Being tested
- Omega-3 supplement group, Full feeding without receiving any supplementation group
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 supplement groupDietary supplement
35 Neonates were given Omega 3 in a dose of 40mg/kg/day (8), after establishment of full-feeding and for 2 weeks duration. Omega-300 (Montana pharmaceutical industry) capsule was used which contains 1000mg Omega 3 fatty acids.
Full feeding without receiving any supplementation groupOther
35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 supplement group | Experimental | This group included 35 full term Intrauterine Growth Restriction( IUGR) neonates, who received omega-3 supplement (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day) after establishment of full feeding. Receives: Dietary Supplement: Omega-3 supplement group |
| Full feeding without receiving any supplementation group | Experimental | This group included 35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation. Receives: Other: Full feeding without receiving any supplementation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of serum leptin
Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day)supplementation on level of serum leptin in neonates with Intrauterine growth restriction (IUGR).
Measured: 4 weeks from admission to neonatal intensive care unit
Secondary outcomes (1)
Level of serum lipid
Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day) supplementation on level of serum lipid in neonates with Intrauterine growth restriction (IUGR).
Measured: 4 weeks from admission to neonatal intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Jun 2021
- Primary completion1 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid ProfileStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Rabie El-Sheikh, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242107
- Sponsor's protocol ID
- 35199/9/22
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available upon a reasonable request from the corresponding author
Publications
Elsheikh M, El Amrousy D, El-Mahdy H, Dawoud H, Harkan A, El-Barky A. Lipid profile after omega-3 supplementation in neonates with intrauterine growth retardation: a randomized controlled trial. Pediatr Res. 2023 Oct;94(4):1503-1509. doi: 10.1038/s41390-023-02632-z. Epub 2023 May 18.
PubMed 37202530
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT05242107
- Acronym / sponsor ID
- 35199/9/22
- Conditions
- Lipid Profile, Neonates, Intrauterine Growth Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 16 Feb 2022 (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.
The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)
Detailed description
Intrauterine growth restriction is a major cause of perinatal mortality and morbidity .
It is noted to affect approximately 5-15 % of pregnant women. Egypt has one of the highest incidences of Intrauterine Growth Restriction. The incidence of IUGR varies among countries, populations, races and increases with decreasing gestational age. 14 to 20 million infants have been affected with Intrauterine Growth Restriction cases in the developing countries annually.
A complex and dynamic interaction of maternal, placental and fetal environment is involved in ensuring normal fetal growth. An imbalance or lack of coordination in this complex system may lead to Intrauterine Growth Restriction. Intrauterine Growth Restriction( IUGR) results in significant perinatal and long-term complications, including increased neonatal mortality and morbidity and higher risk for developing metabolic syndrome later in life.
Physiological differences have been noted in growth restricted infants. Intrauterine amino acid disturbances similar to biochemical changes seen in postnatal protein deprived states have been detected. Protein metabolism defect and altered lipid metabolism also have been described.
Undernourishment in utero appears to be associated with persisting changes in the metabolic functions. Birth weight influences the lipoprotein profile and cholesteryl ester transfer protein, which promotes a proatherogenic lipoprotein profile in plasma by determining chemical, physical and biological properties of the respective lipoprotein particle in neonates.
Recent research suggests that several of major disease of later life, including coronary heart disease, hypertension \& type II diabetes originate in impaired intrauterine growth and development. These diseases may be consequence of programming whereby a stimulus or insult at a critical, sensitive period of early life has a permanent effect on structure, physiology and metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 supplement group | Experimental | Dietary Supplement: Omega-3 supplement groupThis group included 35 full term Intrauterine Growth Restriction( IUGR) neonates, who received omega-3 supplement (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day) after establishment of full feeding. |
| Full feeding without receiving any supplementation group | Experimental | Other: Full feeding without receiving any supplementation groupThis group included 35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation. |
Who may qualify
- Ages
- 1 day to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any full-term Intrauterine growth restriction (IUGR) neonate
Key exclusion criteria (6 listed)
- Preterm neonates
- Who died before feeding was established
- Multiple congenital anomalies including GIT anomalies
- Congenital infection
- Cholestasis
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 |
|---|---|---|
| Omega-3 supplement group35 Neonates were given Omega 3 in a dose of 40mg/kg/day (8), after establishment of full-feeding and for 2 weeks duration. Omega-300 (Montana pharmaceutical industry) capsule was used which contains 1000mg Omega 3 fatty acids. | Dietary supplement | Omega-3 supplement group |
| Full feeding without receiving any supplementation group35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation. | Other | Full feeding without receiving any supplementation group |
Primary outcome
Level of serum leptin
Time frame: 4 weeks from admission to neonatal intensive care unit
Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day)supplementation on level of serum leptin in neonates with Intrauterine growth restriction (IUGR).
1 secondary outcome
Level of serum lipid
Time frame: 4 weeks from admission to neonatal intensive care unit
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 16 Feb 2022.
- Derived from this study: PubMed 37202530Elsheikh M, El Amrousy D, El-Mahdy H, Dawoud H, Harkan A, El-Barky A. Lipid profile after omega-3 supplementation in neonates with intrauterine growth retardation: a randomized controlled trial. Pediatr Res. 2023 Oct;94(4):1503-1509. doi: 10.1038/s41390-023-02632-z. Epub 2023 May 18.
- Individual participant dataSharing planned: Yes. The study will be available upon a reasonable request from the corresponding author
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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?
A study testing Omega-3 supplement group and Full feeding without receiving any supplementation group in people with Lipid Profile and Neonates, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 6 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 16 Feb 2022. 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 Egypt. 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?
Level of serum leptin (time frame: 4 weeks from admission to neonatal intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242107, which also lists 1 linked publication.
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 16 Feb 2022.