The effect of 4 or 6 months exclusive breastfeeding on infant breast-milk intake, growth and iron status

Breastfeeding and child health: randomized controlled trial on the impact of age of introduction of weaning foods

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41946519

Enrollment

100

Registered

2012-04-04

Start date

2007-11-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy term infant feeding Nutritional, Metabolic, Endocrine

Interventions

Exclusive breastfeeding for 6 months compared to exclsuive breastfeeding to 4 months with introduction of solid foods alongside continued breastfeeding.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy term infant (>37 weeks gestation) 2. No health issues affecting growth 3. No other siblings enrolled in the study 4. Exclusively breast-fed at age 4 months

Exclusion criteria

Exclusion criteria: Infant not exclusively breast-fed at age 4 months

Design outcomes

Primary

Measure	Time frame
1. Feasibility 1.1 Proportion of mothers that will breastfeed exclusively for 6 months 1.2 Proportion of mothers randomized at 4 months (from those invited to participate) 2. Measurements at 6 months 2.1 Infant breast milk intake (by stable isotopes) 2.2 Infant growth 2.3 Infant iron status	—

Secondary

Measure	Time frame
1. Infant food intake 2. Infant body composition 3. Occurrence of upper respiratory infections and diarrheal episodes (dichotomous variables)	—

Countries

Iceland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026