Recent Updates
Recently added Catalysts

Vitamin A or Beta-Carotene Supplements

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment59,666
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00198822Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in BangladeshPHASE3 COMPLETED 59,666Aug 1, 2001Mar 1, 2008Mar 7, 20123 United States, Bangladesh
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range15 Years — 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
Unlock Eligibility Criteria