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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Other trials in United States

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 groups in NCT03750968
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.

26 Sep 201931 Jan 2022

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)

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 37247819
Addo 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Nutritional Status, Nutrient Deficiency

All Nutrient Deficiency trials

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.

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

Results posted to the registry on 11 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carotenoid Group	24	21
Control Group	23	20

Primary outcome: Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant

Time frame: up to 13 weeks gestation to birth. Mean (Standard Error). Unit: unitless

Measure	Carotenoid Group n = 21	Control Group n = 20
Value	12244 (688)	7343 (470)

Population analysed: Participants who did not complete the final study visit were not included in the analysis.

Primary outcome: Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant

Time frame: up to 13 weeks gestation to birth. Mean (Standard Error). Unit: Nanograms per milliliter

Measure	Carotenoid Group n = 21	Control Group n = 20
Value	1030.2 (86.8)	252.0 (33.4)

Population analysed: Participants who did not complete the final study visit were not included in the analysis.

Primary outcome: Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant

Time frame: up to 13 weeks gestation to birth. Mean (Standard Error). Unit: Raman units

Measure	Carotenoid Group n = 21	Control Group n = 20
Value	55419 (2421)	38475 (1932)

Population analysed: Participants who did not complete a final study visit were excluded from final data analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carotenoid Group	2 of 24 (8.3%)	6 of 24 (25%)	0 of 24
Control Group	0 of 23 (0%)	8 of 23 (34.8%)	0 of 23

Limitations and caveats (from the sponsor): A limitation of this study was its lack of participant racial, ethnic and socioeconomic diversity. Also, by design, this first-in-humans, randomized clinical trial was limited to low-risk pregnancies. Due to funding and logistical limitations, we could not follow the mothers and their infants beyond their postpartum visit. This meant we were not able to assess the role of maternal breastmilk as a continued source of lutein an zeaxanthin during the first months of life.

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

Related trials for Nutrient Deficiency

Enrolling by invitation
PROmega Pilot Study of Clinic-based DHA Blood Screening in Early Pregnancy
Nutrient Deficiency
Recruiting
Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda
Nutrient Deficiency
RecruitingObservational study
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition Pregnancy, Malnutrition in Children
Recruiting
Conversion to SADI-S, RYGB or OAGB After Failed Sleeve
Weight Loss, Bariatric Surgery Candidate
Enrolling by invitationObservational study
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Nutritional Status, Nutrient Deficiency

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.