Lactation Fortification Study

NCT01747668 | Completed Phase 3

• 1 other identifier: AL05
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Lactation

Keywords

Mother and Infant Pairs

Outcome Measures

Primary Outcomes (1)

• Breast milk concentration of carotenoids

  1 - 43 days

Secondary Outcomes (1)

• Breast milk concentration of fatty acids

  1 - 43 days

Other Outcomes (1)

• Blood levels of nutrients and fatty acids

  1 and 43 days

Study Arms (3)

Control Supplement

PLACEBO COMPARATOR

soft-gel placebo capsules, 2 capsules from the placebo bottle per day

Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)

Experimental Supplement A

EXPERIMENTAL

soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day

Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule; Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)

Experimental Supplement B

EXPERIMENTAL

soft-gel capsules; 2 capsules from the experimental bottle per day

Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule

Interventions

Similac Prenatal Vitamin soft-gel capsule DIETARY_SUPPLEMENT

One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group

Experimental Supplement A; Experimental Supplement B

Placebo (soybean oil and dl-alpha-tocopheryl acetate) DIETARY_SUPPLEMENT

Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A

Control Supplement; Experimental Supplement A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g
• Pre-pregnancy BMI \</= 30
• Mother is ≥ 18 years of age
• Mother is 4-6 weeks postpartum and has been successfully continuously lactating
• 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
• Mother agrees to abstain from the use of non-study supplements throughout the study
• Mother plans to continue breastfeeding for at least 6 weeks from the start of the study
• 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

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• Subject had adverse maternal and/or fetal medical history
• Subject is participating in a non-Abbott approved concomitant trial
• Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (6)

Northpoint Pediatrics, LLC

Indianapolis, Indiana, 46256, United States

Location

Ohio Pediatric Research Association, Inc

Dayton, Ohio, 45414, United States

Location

Ohio Pediatric Research Association, Inc

Kettering, Ohio, 45420, United States

Location

Institute of Clinical Research

Mayfield Heights, Ohio, 44124, United States

Location

The Cleveland Pediatric Research Center, LLC

Parma, Ohio, 44129, United States

Location

The Cleveland Pediatric Research Center, LLC

Westlake, Ohio, 44145, United States

Location

Related Publications (1)

• Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.

  PMID: 24899160 DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Soybean Oil; alpha-Tocopherol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christina Sherry, PhD, RD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 31, 2013

Record last verified: 2013-05

Locations

US (6)