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Electrolyte Supplement

Sodium supplementation algorithm for Growth Disorder (Salt to Grow Trial)

Phase 4
Waitlist Available
Led By Gregory M Sokol, MD
Research Sponsored by Indiana University
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 between 2 weeks of age and discharge or transfer from the nicu or 44 weeks corrected age (whichever occurs first)
Awards & highlights

Salt to Grow Trial Summary

This trial will test whether adding extra salt to the diets of infants who are struggling to grow can help them reach a healthier weight.

Eligible Conditions
  • Postnatal Growth Disorder

Salt to Grow Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 2 weeks of age and discharge or transfer from the nicu or 44 weeks corrected age (whichever occurs first)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 2 weeks of age and discharge or transfer from the nicu or 44 weeks corrected age (whichever occurs first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in somatic growth (head circumference)
Body Weight Changes
Body Weight Changes
+7 more

Salt to Grow Trial Design

2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Standard of care sodium supplementation as directed by the medical care team
Group II: Sodium supplementation algorithmActive Control1 Intervention
Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,287 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,284 Total Patients Enrolled
Gregory M Sokol, MDPrincipal Investigator - Indiana University
Indiana University

Media Library

Sodium (Electrolyte Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03889197 — Phase 4
Growth Disorder Research Study Groups: Control, Sodium supplementation algorithm
Growth Disorder Clinical Trial 2023: Sodium Highlights & Side Effects. Trial Name: NCT03889197 — Phase 4
Sodium (Electrolyte Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03889197 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this trial?

"Per the information hosted by clinicaltrials.gov, this medical trial is in need of recruitment and was initially made available on July 1st 2019 with its last edit being conducted November 8th 2021."

Answered by AI

What eligibility criteria is necessary to participate in this clinical experiment?

"This clinical trial is searching for 90 newborns that suffer from a growth disorder and are between 7 days to 16 days old. The requirements include having been born with gestational age of 25 0/7 - 29 6/7, weighing at least 500 grams at birth, being admitted within the first week after delivery, and not exceeding 17 days of age at the moment of enrollment."

Answered by AI

Is the Sodium supplementation algorithm risk-free for patients?

"There is a wealth of evidence validating the safety profile of Sodium supplementation algorithm, so it has been graded a 3 on our ranking system."

Answered by AI

Is this experiment open to people of all ages, or are there age restrictions?

"This clinical trial can only be accessed by patients aged between seven days and sixteen days old. Persons below eighteen years of age have 6 other trials to choose from, while those above sixty-five may select from two options."

Answered by AI

How many individuals have been enlisted in this clinical experiment?

"Correct. According to the data provided by clinicaltrials.gov, this medical research is actively recruiting participants; it was first published on July 1st 2019 and has been updated for the last time on November 8th 2021. 90 individuals are needed from three different sites involved in the trial."

Answered by AI
~16 spots leftby Mar 2025