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New Infant Formula for Obesity
N/A
Waitlist Available
Led By Parth Shah, MD FAPCR
Research Sponsored by Jovie USA, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new baby formula to see if it helps healthy, full-term infants grow as well as other feeding options. The study will observe the growth of babies fed the new formula over a few months.
Eligible Conditions
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight gain from baseline to 16 weeks feeding
Secondary study objectives
Head Circumference gain from baseline to 16 weeks feeding
Length gain from baseline to 16 weeks feeding
Volume of formula consumed during 3-consecutive day intervals
Other study objectives
Assessment of AEs
Caregiver report of stool characteristics obtained during 3-consecutive day intervals
Caregiver report of tolerance obtained during 3-consecutive day intervals
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: New Infant FormulaExperimental Treatment1 Intervention
New infant formula for healthy term infants
Group II: Commercial Infant FormulaActive Control1 Intervention
Standard, commercially available infant formula for healthy term infants
Group III: Human MilkActive Control1 Intervention
Breastfed infants serve as a reference group
Find a Location
Who is running the clinical trial?
Jovie USA, LLCLead Sponsor
2 Previous Clinical Trials
719 Total Patients Enrolled
IQVIA RDS Inc.UNKNOWN
3 Previous Clinical Trials
13,978 Total Patients Enrolled
ObvioHealthIndustry Sponsor
11 Previous Clinical Trials
10,732 Total Patients Enrolled
Parth Shah, MD FAPCRPrincipal InvestigatorObvioHealth
Dawn Ross, Director Clinical Project ManagementStudy DirectorIQVIA RDS Inc.