Nutrient DeficiencyPhase 2L-ZIPNCT03750968
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
A Phase 2 study testing Carotenoid Group in people with Nutrient Deficiency and Pregnancy Related, run by Paul S. Bernstein at 1 site in United States.
Trial summary
This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal… 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
- Nutrient Deficiency, Pregnancy Related
- What is being tested?
- Carotenoid Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 31 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated obstetric history and plan to deliver either vaginally or by Caesarian section at the University of Utah for their current pregnancy.
Who cannot join
- Women who have regularly taken carotenoid supplements containing more than 0.5 mg of lutein and/or zeaxanthin daily during the six months prior to screening
- Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).
- Women with conditions associated with high-risk pregnancy such as adolescent pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia, previous premature delivery, drug abuse or other significant medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132
About this study
This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure.
Mothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth.
- Conditions
- Nutrient Deficiency, Pregnancy Related
- Being tested
- Carotenoid Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid GroupDrug
Also called Softgel with lutein and zeaxanthin
Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil
Control GroupDietary supplement
Also called Softgel without lutein and zeaxanthin
Placebo ingredients: Safflower oil
| Study group | Role | What they receive |
|---|---|---|
| Carotenoid group | Experimental | The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Receives: Drug: Carotenoid Group |
| Control group | Active comparator | The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil. Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Measured: up to 13 weeks gestation to birth
Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant
We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Measured: up to 13 weeks gestation to birth
Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant
Maternal skin carotenoid levels are measured in Raman units.
Measured: up to 13 weeks gestation to birth
Secondary outcomes (3)
Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density
Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Measured: Birth
Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography
Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Measured: Birth
Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy
Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Measured: Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start26 Sep 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutrient DeficiencyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul S. Bernstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul S. Bernstein, University of Utah
- Investigators
- Paul S Bernstein, MD, PhD, Principal investigator, University of Utah Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750968
- Sponsor's protocol ID
- IRB # 116610
- Acronym
- L-ZIP
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2018
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addo EK, Allman SJ, Arunkumar R, Gorka JE, Harrison DY, Varner MW, Bernstein PS. Systemic Effects of Prenatal Carotenoid Supplementation in the Mother and her Child: The Lutein and Zeaxanthin in Pregnancy (L-ZIP) Randomized Trial -Report Number 1. J Nutr. 2023 Aug;153(8):2205-2215. doi: 10.1016/j.tjnut.2023.05.024. Epub 2023 May 27.
PubMed 37247819Addo EK, Gorusupudi A, Allman S, Bernstein PS. The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study-carotenoid supplementation during pregnancy: ocular and systemic effects-study protocol for a randomized controlled trial. Trials. 2021 Apr 22;22(1):300. doi: 10.1186/s13063-021-05244-2.
PubMed 33888136
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
- ClinicalTrials.gov ID
- NCT03750968
- Acronym / sponsor ID
- L-ZIP / IRB # 116610
- Conditions
- Nutrient Deficiency, Pregnancy Related
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Paul S. BernsteinUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure.
Mothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotenoid group | Experimental | Drug: Carotenoid GroupThe Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil. |
| Control group | Active comparator | Dietary Supplement: Control GroupThe Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated obstetric history and plan to deliver either vaginally or by Caesarian section at the University of Utah for their current pregnancy.
Key exclusion criteria (3 listed)
- Women who have regularly taken carotenoid supplements containing more than 0.5 mg of lutein and/or zeaxanthin daily during the six months prior to screening
- Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).
- Women with conditions associated with high-risk pregnancy such as adolescent pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia, previous premature delivery, drug abuse or other significant medical illness
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 |
|---|---|---|
| Carotenoid GroupAlso: Softgel with lutein and zeaxanthinSoftgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil | Drug | Carotenoid group |
| Control GroupAlso: Softgel without lutein and zeaxanthinPlacebo ingredients: Safflower oil | Dietary supplement | Control group |
Primary outcome
Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
Time frame: up to 13 weeks gestation to birth
measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant
Time frame: up to 13 weeks gestation to birth
We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant
Time frame: up to 13 weeks gestation to birth
Maternal skin carotenoid levels are measured in Raman units.
3 secondary outcomes
Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density
Time frame: Birth
Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography
Time frame: Birth
Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy
Time frame: Birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37247819Addo EK, Allman SJ, Arunkumar R, Gorka JE, Harrison DY, Varner MW, Bernstein PS. Systemic Effects of Prenatal Carotenoid Supplementation in the Mother and her Child: The Lutein and Zeaxanthin in Pregnancy (L-ZIP) Randomized Trial -Report Number 1. J Nutr. 2023 Aug;153(8):2205-2215. doi: 10.1016/j.tjnut.2023.05.024. Epub 2023 May 27.
- Derived from this study: PubMed 33888136Addo EK, Gorusupudi A, Allman S, Bernstein PS. The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study-carotenoid supplementation during pregnancy: ocular and systemic effects-study protocol for a randomized controlled trial. Trials. 2021 Apr 22;22(1):300. doi: 10.1186/s13063-021-05244-2.
- Individual participant dataSharing planned: No
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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.
Paul S Bernstein, MD, PhD principal investigator
University of Utah Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carotenoid Group in people with Nutrient Deficiency and Pregnancy Related, run by Paul S. Bernstein at 1 site 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 1 inclusion and 3 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 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant (time frame: up to 13 weeks gestation to birth). The study lists 3 primary outcomes in all. 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 NCT03750968, which also lists 2 linked publications.
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 11 Jul 2023.