Association Between Soy Based Formula in Infancy and Puberty
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02908971|
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : October 6, 2016
Background: Children in industrialized and developing countries have a higher tendency to present earlier signs of puberty. One hypothesis includes the hormonal effects of phytoestrogens found in soy products.
Objective: to examine the association between consumption of soy-based food in early infancy and childhood and the incidence of early or precocious puberty and overweight in school-aged children.
Methods: the study population for this case control study is randomized from a prospectively followed cohort of all babies born at Assaf Haroffeh medical center and followed for milk allergy signs and food intake until the age of 3 years (A nested cohort). It is divided to those who were allergic to milk, and thus consumed only soy based formula and food during infancy and childhood (soy group) and a randomized control group who consumed non-soy based intake. For both groups data are available of food habits during infancy and collected from 3 days food diaries during the current study. Physical examination, including weight , height, blood pressure and Tanner Pubertal Staging will performed annually.
|Condition or disease||Intervention/treatment|
|Puberty and Body Composition||Behavioral: soy based formula at infancy|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Association Between Soy Based Formula Consumption During Infancy and the Timing of Pubertal Signs and BMI-SDS|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2020|
Soy based formula
"soy group" will include children from the children who had milk allergy, and consumed a soy-based substitute formula for longer than three months and agreed to participate in this study.
Behavioral: soy based formula at infancy
The intervention is only past history of soy consumption
The control group will included children (at a rate of 2:1) who will be assigned randomly from the healthy population at the initial cohort, and who will agree to participate.
- Age of adrenarche signs [ Time Frame: 5 years ]Age of adrenarche signs will be compared between soy and control groups
- Age of gonadarche signs [ Time Frame: 5 years ]Age of gonadarche signs will be compared between soy and control groups
- comparison of rate of Overweight and obesity [ Time Frame: 5 years ]BMI-SDS will be compared between groups
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): NCT02908971
|Contact: Marianna Rachmiel, MDfirstname.lastname@example.org|
|Contact: Avital Leshememail@example.com|
|Assaf Haroffeh Medical center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Marianna Rachmiel, MD 972-8-9542007 firstname.lastname@example.org|
|Principal Investigator: Marianna Rachmiel, MD|
|Principal Investigator: Galia Askapa, MD|
|Principal Investigator:||Marianna Rachmiel, MD||Assaf Haroffeh Medical Center|