Trials / Completed
CompletedNCT04671576
Growth and Safety Clinical Trial on a New Infant Formula.
Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 176 (actual)
- Sponsor
- Nara Organics · Industry
- Sex
- All
- Age
- 1 Day – 14 Days
- Healthy volunteers
- Accepted
Summary
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
Detailed description
A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Control Infant Formula | Powder, standard commercial infant formula. |
| OTHER | Organic Infant Formula | Powder, organic milk-based infant formula. |
Timeline
- Start date
- 2021-02-12
- Primary completion
- 2022-08-12
- Completion
- 2022-08-12
- First posted
- 2020-12-17
- Last updated
- 2022-09-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04671576. Inclusion in this directory is not an endorsement.