Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
89 participants
INTERVENTIONAL
2012-11-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Supplement
soft-gel placebo capsules, 2 capsules from the placebo bottle per day
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
Experimental Supplement A
soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
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
Experimental Supplement B
soft-gel capsules; 2 capsules from the experimental bottle per day
Similac Prenatal Vitamin soft-gel capsule
One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina Sherry, PhD, RD
Role: STUDY_CHAIR
Abbott Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States
Ohio Pediatric Research Association, Inc
Dayton, Ohio, 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, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AL05
Identifier Type: -
Identifier Source: org_study_id