Last reviewed · How we verify
NCT05508750
Growth and Safety Clinical Trial on a New Infant Formula
NA trial testing New Infant Formula in Weight Gain in 420 participants. Completed in 2 January 2024.
2 January 2024
Quick facts
| Lead sponsor | Jovie USA, LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 420 |
| Start date | 21 September 2022 |
| Primary completion | 2 January 2024 |
| Estimated completion | 2 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- New Infant Formula
- Commercial Infant Formula
Conditions studied
- Weight Gain — all drugs for Weight Gain →
Sponsor
Jovie USA, LLC
Who can join
Adults 0 Days to 14 Days, any sex, with Weight Gain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05508750
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of New Infant Formula
Trials testing the same drug.
- NCT03563391 — A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure · NA · completed
Other recruiting trials for Weight Gain
Currently open trials in the same condition.
- NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
- NCT07325500 — Incretin Microdosing for Cardiometabolic Health in People With HIV · Phase 2 · recruiting
- NCT07190170 — Time Restricted Eating for WeIght LoSs MainTenance-2 · NA · recruiting
- NCT06511310 — Exercise, Brain Activity, and Weight Maintenance · NA · recruiting
- NCT04252547 — Effect of Kangaroo Care on Test Weighing · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05508750 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jovie USA, LLC
- Last refreshed: 17 January 2024
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/NCT05508750.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing