Lactation Fortification Study

Lactation Clinical Trial

Official title:

Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747668
• Other study ID #: AL05
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2012
• Last updated: May 30, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To investigate the impact of nutrient supplementation during lactation on levels in breast milk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

1. Mother with singleton birth, 37-42 weeks gestation and = 2490g

2. Pre-pregnancy BMI </= 30

3. Mother is = 18 years of age

4. Mother is 4-6 weeks postpartum and has been successfully continuously lactating

5. Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample

6. Mother agrees to abstain from the use of non-study supplements throughout the study

7. Mother plans to continue breastfeeding for at least 6 weeks from the start of the study

8. No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Subject had adverse maternal and/or fetal medical history

2. Subject is participating in a non-Abbott approved concomitant trial

3. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lactation

Intervention

Dietary Supplement:
• Similac Prenatal Vitamin soft-gel capsule
One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group
• Placebo (soybean oil and dl-alpha-tocopheryl acetate)
Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A

Locations

Country	Name	City	State
United States	Ohio Pediatric Research Association, Inc	Dayton	Ohio
United States	Northpoint Pediatrics, LLC	Indianapolis	Indiana
United States	Ohio Pediatric Research Association, Inc	Kettering	Ohio
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	The Cleveland Pediatric Research Center, LLC	Parma	Ohio
United States	The Cleveland Pediatric Research Center, LLC	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood levels of nutrients and fatty acids	In mothers at 1 and 43 days In infants at 43 days	1 and 43 days	No
Primary	Breast milk concentration of carotenoids		1 - 43 days	No
Secondary	Breast milk concentration of fatty acids		1 - 43 days	No