NCT04317638

Brief Summary

Lipid profile of full-term infants on different regimens. The aim of the study is to compare infant's lipid profiles on different feeding regimen during the first 6 months of life and its correlation with their mothers' lipid profiles (exclusive breastfeeding and mixed feeding) and to compare infants' lipid profiles on different feeding regimen with each other (including those on exclusive formula feeding).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 19, 2020

Last Update Submit

March 21, 2020

Conditions

Lipid Profile

Outcome Measures

Primary Outcomes (2)

  • comparison between lipid profiles of the infants of the 3 groups

    analysis of the results of lipid profiles of infants on different feeding regimens at the age of 14 weeks and 6 months

    baseline

  • correlation of lipid profiles of infants and their mothers

    analysis of the results of lipid profiles of infants on exclusive breast feeding and mixed feeding (breast and formula feeding) and the results of lipid profiles of their mothers

    baseline

Study Arms (3)

breastfed group

Infants on exclusive breast feeding for the first 6 months of life and their mothers

Other: Lipid profile

formula fed group

Infants on exclusive formula feeding for the first 6 months of life

Other: Lipid profile

mixed fed group

Infants on mixed feeding (formula \& breast feeding) and their mothers

Other: Lipid profile

Interventions

Lipid profileOTHER

3 ml of venous blood from the breastfed and infants and mothers of the breastfed and mixed fed infants will be taken under aseptic precautions for determination of triglycerides (TG), cholesterol, high density lipoprotein (HDL), very low density lipoprotein (LDL) at the age of 14 ± 2 weeks and the age of 6 months.

breastfed groupformula fed groupmixed fed group

Eligibility Criteria

Age12 Weeks - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants seeking medical advice in the outpatient clinics of Assiut University Children Hospital

You may qualify if:

  • Apparently healthy infants during the first 6 months of life on different feeding regimen

You may not qualify if:

  • Infants with perinatal problems .e.g.,
  • birth asphyxia
  • premature rupture of membranes
  • hypoglycemia
  • hypothermia
  • meconium stained amniotic fluid
  • pathological jaundice
  • congenital malformations
  • clinical evidence of chromosomal abnormalities
  • Infants born to mothers having any chronic disease e.g.,
  • diabetes mellitus
  • gestational diabetes
  • hypertension
  • pre-eclampsia
  • eclampsia
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Martin MA, Lassek WD, Gaulin SJ, Evans RW, Woo JG, Geraghty SR, Davidson BS, Morrow AL, Kaplan HS, Gurven MD. Fatty acid composition in the mature milk of Bolivian forager-horticulturalists: controlled comparisons with a US sample. Matern Child Nutr. 2012 Jul;8(3):404-18. doi: 10.1111/j.1740-8709.2012.00412.x. Epub 2012 May 24.

    PMID: 22624983BACKGROUND

  • Harit D, Faridi MM, Aggarwal A, Sharma SB. Lipid profile of term infants on exclusive breastfeeding and mixed feeding: a comparative study. Eur J Clin Nutr. 2008 Feb;62(2):203-9. doi: 10.1038/sj.ejcn.1602692. Epub 2007 Feb 28.

    PMID: 17327867BACKGROUND

  • Owen CG, Martin RM, Whincup PH, Smith GD, Cook DG. Does breastfeeding influence risk of type 2 diabetes in later life? A quantitative analysis of published evidence. Am J Clin Nutr. 2006 Nov;84(5):1043-54. doi: 10.1093/ajcn/84.5.1043.

    PMID: 17093156BACKGROUND

Study Officials

  • Nagla H Abu Faddan, PHD

    Assiut University Children Hospital

    STUDY CHAIR

  • Amir M Abo El-Gheit, PHD

    Assiut University Children Hospital

    STUDY CHAIR

Central Study Contacts

Maria Remon Riad, M.B.B.CH

CONTACT

+201019239937maria.r.riad@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

March 24, 2020

Record last verified: 2020-03