LactationPhase 3NCT01747668
Lactation Fortification Study
A Phase 3 study testing Similac Prenatal Vitamin soft-gel capsule in people with Lactation, run by Abbott Nutrition at 6 sites in United States.
Trial summary
To investigate the impact of nutrient supplementation during lactation on levels in breast milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Similac Prenatal Vitamin soft-gel capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2012to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ohio Pediatric Research Association, Inc
Dayton, Ohio, 45414
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46256
Ohio Pediatric Research Association, Inc
Kettering, Ohio, 45420
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
The Cleveland Pediatric Research Center, LLC
Parma, Ohio, 44129
The Cleveland Pediatric Research Center, LLC
Westlake, Ohio, 44145
About this study
Official title: Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
- Conditions
- Lactation
- Being tested
- Similac Prenatal Vitamin soft-gel capsule, Placebo (soybean oil and dl-alpha-tocopheryl acetate)
- Keywords
- Mother and Infant Pairs
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Similac Prenatal Vitamin soft-gel capsuleDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Control Supplement | Placebo comparator | soft-gel placebo capsules, 2 capsules from the placebo bottle per day Receives: 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 Receives: 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 Receives: Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk concentration of carotenoids
Measured: 1 - 43 days
Secondary outcomes (1)
Breast milk concentration of fatty acids
Measured: 1 - 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Sherry, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747668
- Sponsor's protocol ID
- AL05
- Status last verified
- May 2013
- First submitted
- 10 Dec 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24899160
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
- ClinicalTrials.gov ID
- NCT01747668
- Acronym / sponsor ID
- AL05
- Conditions
- Lactation
- Keywords
- Mother and Infant Pairs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Supplement | Placebo comparator | Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)soft-gel placebo capsules, 2 capsules from the placebo bottle per day |
| Experimental Supplement A | Experimental | Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule, Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day |
| Experimental Supplement B | Experimental | Dietary Supplement: Similac Prenatal Vitamin soft-gel capsulesoft-gel capsules; 2 capsules from the experimental bottle per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Similac Prenatal Vitamin soft-gel capsuleOne capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group | Dietary supplement | Experimental Supplement A, Experimental Supplement B |
| 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 | Dietary supplement | Control Supplement, Experimental Supplement A |
Primary outcome
Breast milk concentration of carotenoids
Time frame: 1 - 43 days
1 secondary outcome
Breast milk concentration of fatty acids
Time frame: 1 - 43 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Derived from this study: PubMed 24899160Sherry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Sherry, PhD, RD study chair
Abbott Nutrition
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Similac Prenatal Vitamin soft-gel capsule in people with Lactation, run by Abbott Nutrition at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk concentration of carotenoids (time frame: 1 - 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01747668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.