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Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects (L-ZIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750968
Recruitment Status : Active, not recruiting
First Posted : November 23, 2018
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Paul S. Bernstein, University of Utah

Study Description
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Brief 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 6.0 milligrams of lutein and 0.5 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.


Condition or disease Intervention/treatment Phase
Nutrient Deficiency Pregnancy Related Drug: Carotenoid Group Dietary Supplement: Control Group Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Lutein

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carotenoid group
The Carotenoid group will receive a commercially available prenatal vitamin/mineral tablet plus a softgel containing lutein/zeaxanthin, vitamin E and docosahexaenoic acid (DHA).
 Drug: Carotenoid Group
DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU, Lutein 6mg
Other Name: DHA Softgel with lutein and zeaxanthin
Active Comparator: Control group
The Control group will receive the same prenatal vitamin/mineral tablet plus a softgel containing only vitamin E and DHA.
 Dietary Supplement: Control Group
DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU
Other Name: DHA Softgel without lutein and zeaxanthin


Outcome Measures
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Primary Outcome Measures :
  1. 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 volume

  2. Change in maternal serum carotenoid levels from enrollment to birth of infant [ Time Frame: up to 13 weeks gestation to birth ]
    measured in micrograms per milliliter

  3. Change in maternal skin carotenoid levels from enrollment to birth of infant [ Time Frame: up to 13 weeks gestation to birth ]
    measured in raman counts


Secondary Outcome Measures :
  1. Comparison of macular carotenoid levels between infants [ Time Frame: Birth ]
    Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids

  2. Comparison of serum carotenoid levels between infants [ Time Frame: Birth ]
    Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids

  3. Comparison of skin carotenoid levels between infants [ Time Frame: Birth ]
    Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750968


Locations
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United States, Utah
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Paul S. Bernstein
Investigators
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Principal Investigator: Paul S Bernstein, MD, PhD University of Utah Moran Eye Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paul S. Bernstein, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier: NCT03750968    
Other Study ID Numbers: IRB # 116610
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs