Study of milk composition from adequately nourished and undernourished mothers.

Phase 4

Completed

• Conditions: Health Condition 1: E440- Moderate protein-calorie malnutrition

• Registration Number: CTRI/2014/11/005199
• Lead Sponsor: estec Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-04-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 142

Inclusion Criteria

1.All mothers who delivered term infants, either SGA or AGA

2.Mothers between 18 and 40 years of age inclusive, at the time of enrolment

3.Having decided to predominantly breast-feed their new born baby at least until 6 months of age

4.Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study

5.Willing to provide informed consent according to the requirements of local regulations.

Exclusion Criteria

1.Preterm delivery (<= 36 weeks + 6 days completed) of gestational age)

2.Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study

3.Having a BMI >= 25.0

4.Chewing tobacco, smoking or drinking alcohol ( > 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study

5.Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated

6.Having diabetes or gestational diabetes mellitus

7.Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease

8.Subject unable to comply with study procedures or unable to come to hospital for the study visits.

Study & Design

• Study Type: Observational
• Study Design: Not specified