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Vitamin A or Beta-Carotene Supplements

Phase 3

Vitamin A Deficiency | Unknown | Other |Sight Sciences, Inc.|Last Updated: Mar 7, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment59,666

FDA Designations

No designations recorded

Clinical trial landscape

Vitamin A or Beta-Carotene Supplements · 1 trial · 3 indications

Phase 3 1
NCT00198822Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in BangladeshVitamin A Deficiency
COMPLETED59,666 Analytics
PHASE3COMPLETED
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
Vitamin A Deficiency
NCT0019882259,666
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Study Endpoints

Primary Endpoints

All-cause, Pregnancy-related Mortality
Deaths during pregnancy through 12 weeks postpartum

Mortality evaluated on intent-to-treat basis

Secondary Endpoints

All-cause 3-month Infant Mortality
Deaths through the 1st 12 weeks of life
Maternal Morbidity, Including Obstetric Complications
through the 1st 24 weeks following termination of pregnancy
Gestational Age at Birth
within 24 weeks after birth
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALWeekly oral supplement with 7000 µg retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
2EXPERIMENTALWeekly oral supplement with 42 mg of beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
3PLACEBO_COMPARATORWeekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy

Interventions

NameTypeDescription
Vitamin A or Beta-Carotene SupplementsDIETARY_SUPPLEMENTweekly dosage of either 7000 µg retinol equivalents as preformed vitamin A or 42 mg of beta-carotene from 1st trimester of pregnancy through 12 weeks after termination of pregnancy
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Eligibility Criteria

Age Range15 Years to 49 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Married women of reproductive age * First pregnancy during time period of trial Exclusion Criteria: * Premenarchial girls * Married women with a previous pregnancy enrolled into the trial * Previously married women who have moved into the study area * Single women (never mar...

Countries:United StatesBangladesh
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Frequently asked questions about Vitamin A or Beta-Carotene Supplements

What is Vitamin A or Beta-Carotene Supplements used for?

Vitamin A or Beta-Carotene Supplements are used for Vitamin A Deficiency, specifically to study the impact of maternal supplementation on maternal and infant mortality in Bangladesh. The investigational product is being studied in a Phase 3 clinical trial.

Who makes Vitamin A or Beta-Carotene Supplements?

Sight Sciences, Inc. (NASDAQ: SGHT) is developing Vitamin A or Beta-Carotene Supplements. The company is conducting a Phase 3 clinical trial to evaluate the supplement's effects on maternal and infant mortality in vitamin A deficient populations.

What phase is Vitamin A or Beta-Carotene Supplements in?

Vitamin A or Beta-Carotene Supplements is in Phase 3 clinical development. The trial is completed, with 59,666 participants enrolled. The study is randomized, double-blind, and placebo-controlled, focusing on maternal and infant mortality outcomes.

What clinical trials is Vitamin A or Beta-Carotene Supplements in?

Vitamin A or Beta-Carotene Supplements is associated with one completed Phase 3 trial, NCT00198822, titled 'Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh.' The trial enrolled 59,666 female participants aged 15 years and older in the United States and Bangladesh.

Is Vitamin A or Beta-Carotene Supplements FDA approved?

Vitamin A or Beta-Carotene Supplements is investigational and not FDA approved. It is in Phase 3 clinical development, with one completed trial. The product is being studied for its potential to reduce maternal and infant mortality in vitamin A deficient populations.