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Diastolic Blood Pressure and Lipid Profile in Infants (ERAhmed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612427
Recruitment Status : Unknown
Verified July 2018 by El-Shazly Rabeeh Ahmed, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
El-Shazly Rabeeh Ahmed, Assiut University

Study Description
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Brief 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. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.

Condition or disease Intervention/treatment
Breastfeeding, Exclusive Dietary Supplement: S. Cholesterol S. Triglyceride

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
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Breastfed infants
Infants depending on breastfeeding S. Cholesterol S. Triglycerides S. HDL Cholesterol
 Dietary Supplement: S. Cholesterol S. Triglyceride
S. Cholesterol S. Triglycerides
Other Name: Blood pressure
Formula-fed infants
Infants have formula feeding S. Cholesterol S. Triglycerides S. HDL Cholesterol
 Dietary Supplement: S. Cholesterol S. Triglyceride
S. Cholesterol S. Triglycerides
Other Name: Blood pressure


Outcome Measures
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Primary Outcome Measures :
  1. Diastolic blood pressure [ Time Frame: Around one year ]
    Value of Infants feeding


Secondary Outcome Measures :
  1. Serum cholesterol level [ Time Frame: Around one year ]
    Value of breastfeeding


Eligibility Criteria
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Ages Eligible for Study:   10 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients will be recruited outpatient clinic of Assiut pediatric hospital
Criteria

Inclusion Criteria:

  1. Breastfed infants
  2. Formula-fed infants
  3. Raw milk fed infants

  4. Mixed fed infants

    1. Breast milk plus raw milk
    2. Breast milk plus formula

Exclusion Criteria:

1. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612427


Contacts
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Contact: El-Shazly Ahmed, MBBCh 01000690960 Shazliahmed777@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: El-Shazly Ahmed, MBBCh Assiut University
More Information
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Responsible Party: El-Shazly Rabeeh Ahmed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03612427    
Other Study ID Numbers: ERAhmed AssiutU
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No