Last reviewed · How we verify
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Phase 2 trial testing Carotenoid Group in Nutrient Deficiency in 47 participants. Completed in 31 January 2022.
| Lead sponsor | Paul S. Bernstein |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 47 |
| Start date | 26 September 2019 |
| Primary completion | 31 January 2022 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across United States |
Paul S. Bernstein — full company profile →
18 and older, female only, with Nutrient Deficiency or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 12244 | ± 688 |
| Control Group | 7343 | ± 470 |
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
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 1030.2 | ± 86.8 |
| Control Group | 252.0 | ± 33.4 |
Maternal skin carotenoid levels are measured in Raman units.
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 55419 | ± 2421 |
| Control Group | 38475 | ± 1932 |
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
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 0.05 | ± 0.01 |
| Control Group | 0.04 | ± 0.01 |
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
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 270.5 | ± 29.1 |
| Control Group | 54.5 | ± 6.6 |
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
| Group | Value | 95% CI |
|---|---|---|
| Carotenoid Group | 31656 | ± 1279 |
| Control Group | 23011 | ± 869 |
Time frame: 8 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Carotenoid Group | Control Group |
|---|---|---|---|
| Down syndrome | Congenital, familial and genetic disorders | — | — |
| Multiple congenital abnormalities | Congenital, familial and genetic disorders | — | — |
| Reaction | System | Carotenoid Group | Control Group |
|---|---|---|---|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | — | — |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | — | — |
| COVID-19 | Infections and infestations | — | — |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | — | — |
| Anemia | Pregnancy, puerperium and perinatal conditions | — | — |
| Exacerbated acne | Pregnancy, puerperium and perinatal conditions | — | — |
| Itching | Skin and subcutaneous tissue disorders | — | — |
| Torn placenta at delivery | Pregnancy, puerperium and perinatal conditions | — | — |
| Cholestasis | Hepatobiliary disorders | — | — |
| Sinus infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Worsening depression | Psychiatric disorders | — | — |
| Nose laceration | Injury, poisoning and procedural complications | — | — |
| Preterm delivery | Pregnancy, puerperium and perinatal conditions | — | — |
Most-reported serious reactions: Down syndrome, Multiple congenital abnormalities.
Data from ClinicalTrials.gov NCT03750968 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03750968.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing