Breastfeeding, ExclusiveERAhmedNCT03612427
Diastolic Blood Pressure and Lipid Profile in Infants
An observational study of Breastfeeding, Exclusive, run by Assiut University.
Trial summary
The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Read more about this study
- Who is it for?
- Ages 10 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- S. Cholesterol S. Triglyceride
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Dec 2019
- 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 10 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients will be recruited outpatient clinic of Assiut pediatric hospital
Who may be able to join
- Breastfed infants
- Formula-fed infants
- Raw milk fed infants
- Mixed fed infants
- Breast milk plus raw milk
- Breast milk plus formula
Who cannot join
- 1. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).
The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.
Read the detailed description
The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD, since they have faster early growth rate and higher risk of overweight, type 2 diabetes, high blood pressure, and unfavorable blood lipid profile in adult age. Formula-fed preterm infants have higher serum C-reactive protein (CRP) concentration, higher serum low-density lipoprotein to high-density lipoprotein (LDL:HDL) ratio, and higher serum apolipoprotein B to apolipoprotein A1 (apoB:apoA1) ratio in adolescence as compared with preterm infants receiving banked breast milk.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- S. Cholesterol S. Triglyceride
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S. Cholesterol S. TriglycerideDietary supplement
Also called Blood pressure
- Cholesterol S. Triglycerides
| Study group | Role | What they receive |
|---|---|---|
| Breastfed infants | Infants depending on breastfeeding S. Cholesterol S. Triglycerides S. HDL Cholesterol Receives: Dietary Supplement: S. Cholesterol S. Triglyceride | |
| Formula-fed infants | Infants have formula feeding S. Cholesterol S. Triglycerides S. HDL Cholesterol Receives: Dietary Supplement: S. Cholesterol S. Triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic blood pressure
Value of Infants feeding
Measured: Around one year
Secondary outcomes (1)
Serum cholesterol level
Value of breastfeeding
Measured: Around one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Shazly Rabeeh Ahmed, Assiut University
- Investigators
- El-Shazly Ahmed, MBBCh, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612427
- Sponsor's protocol ID
- ERAhmed AssiutU
- Acronym
- ERAhmed
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).
- ClinicalTrials.gov ID
- NCT03612427
- Acronym / sponsor ID
- ERAhmed / ERAhmed AssiutU
- Conditions
- Breastfeeding, Exclusive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 2 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.
The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.
Detailed description
The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD, since they have faster early growth rate and higher risk of overweight, type 2 diabetes, high blood pressure, and unfavorable blood lipid profile in adult age. Formula-fed preterm infants have higher serum C-reactive protein (CRP) concentration, higher serum low-density lipoprotein to high-density lipoprotein (LDL:HDL) ratio, and higher serum apolipoprotein B to apolipoprotein A1 (apoB:apoA1) ratio in adolescence as compared with preterm infants receiving banked breast milk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfed infants | – | Dietary Supplement: S. Cholesterol S. TriglycerideInfants depending on breastfeeding S. Cholesterol S. Triglycerides S. HDL Cholesterol |
| Formula-fed infants | – | Dietary Supplement: S. Cholesterol S. TriglycerideInfants have formula feeding S. Cholesterol S. Triglycerides S. HDL Cholesterol |
Who may qualify
- Ages
- 10 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients will be recruited outpatient clinic of Assiut pediatric hospital
Key inclusion criteria (6 listed)
- Breastfed infants
- Formula-fed infants
- Raw milk fed infants
- Mixed fed infants
Key exclusion criteria (1 listed)
- 1. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).
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 |
|---|---|---|
| S. Cholesterol S. TriglycerideAlso: Blood pressureS. Cholesterol S. Triglycerides | Dietary supplement | Breastfed infants, Formula-fed infants |
Primary outcome
Diastolic blood pressure
Time frame: Around one year
Value of Infants feeding
1 secondary outcome
Serum cholesterol level
Time frame: Around one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
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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.
El-Shazly Ahmed, MBBCh study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, Exclusive, run by Assiut University.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Shazly Ahmed, MBBCh (01000690960, Shazliahmed777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic blood pressure (time frame: Around one year). 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 2 Aug 2018.