Growth and Safety Clinical Trial on a New Infant Formula.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04671576|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2020
Last Update Posted : April 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Healthy Growth||Other: Control Infant Formula Other: Organic Infant Formula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
A controlled, decentralized, double-blind trial of healthy, term, formula-fed infants randomized to one of two infant formulas:
Control Formula (a standard, commercially available infant formula) or Investigational Formula for 16 weeks.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula.|
|Actual Study Start Date :||January 19, 2021|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Active Comparator: Control Formula
A standard, milk-based, infant formula.
Other: Control Infant Formula
Powder, standard commercial infant formula.
Experimental: Investigational Formula
An organic milk-based infant formula.
Other: Organic Infant Formula
Powder, organic milk-based infant formula.
- Formula intake. [ Time Frame: Study Day 1 to Study Day 112 ]Volume of formula consumed. ml/day
- Weight. [ Time Frame: Study Day 1 to Study Day 112 ]Weight. Weight gain velocity. g and g/day
- Length. [ Time Frame: Study Day 1 to Study Day 112 ]Length. Length gain velocity. cm and cm/day.
- Head circumference. [ Time Frame: Study Day 1 to Study Day 112 ]Head circumference. Head circumference gain velocity. cm and cm/day
- Anthropometry Z-scores. [ Time Frame: Study Day 1 to Study Day 112 ]Weight for age Z-score. Length for age Z-score. Weight for length Z-score. Head circumference for age Z-score.
- Formula tolerance. [ Time Frame: Study Day 1 to Study Day 112 ]Frequency of adverse events. Fussiness. Inconsolable crying.
- Gastrointestinal characteristic. [ Time Frame: Study Day 1 to Study Day 112 ]Stool consistency. Stools/day. Regurgitation. Gas.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671576
|United States, North Carolina|
|Cary, North Carolina, United States, 27519|
|Study Director:||Mera Goodman, MD||Paidion Research, Inc.|
|Principal Investigator:||Tiffany Petty, MD||Telehub Research|