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OpenTrials
Completed

NCT Number: NCT01747668

Lactation Fortification Study

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Northpoint Pediatrics, LLC, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. Breast milk concentration of carotenoids

    Time frame: 1 - 43 days

Secondary outcomes

  1. Breast milk concentration of fatty acids

    Time frame: 1 - 43 days

Other outcomes

  1. Blood levels of nutrients and fatty acids

    Time frame: 1 and 43 days

    In mothers at 1 and 43 days In infants at 43 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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