← Back to Search

Dietary Supplement

SCF Supplementation for Bone Health in Adolescents

Phase 2
Recruiting
Led By Cristina Palacios, PhD
Research Sponsored by Florida International 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
Must not have
Those taking calcium supplements (>500 mg/d) and vitamin D supplements (>400 IU/d) on a regular basis
Subjects with any chronic illness requiring regular medication use.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial will study the effects of soluble corn fiber (SCF) supplementation on bone metabolism in growing adolescents compared to controls, by administering SCF or a placebo to adolescents aged 10-13 years, and assessing bone mass, bone related biomarkers, and the fecal microbiome at baseline and after 12 months.

Who is the study for?
This trial is for healthy adolescents aged 10-13 who fall within the 5th to 85th percentiles for body mass index according to CDC growth charts. It's not open to those regularly taking calcium supplements over 500 mg/day, vitamin D over 400 IU/day, or anyone with a chronic illness requiring regular medication.
What is being tested?
The study tests if adding Soluble Corn Fiber (SCF), alone or with calcium, affects bone metabolism in adolescents compared to a placebo. Participants are randomly assigned into four groups: SCF only, SCF plus calcium, placebo only, and placebo plus calcium; taken twice daily for one year.
What are the potential side effects?
Since this trial involves dietary supplementation rather than drugs, side effects may be minimal but could include gastrointestinal discomfort such as bloating or gas due to fiber intake.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I regularly take more than 500 mg of calcium and more than 400 IU of vitamin D daily.
Select...
I take regular medication for a chronic illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in bone mineral content (BMC)
Change in total bone mineral density (BMD)-z score
Secondary study objectives
Change in body fat
Change in bone alkaline phosphatase
Body Weight Changes
+15 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Soluble Corn Fiber (SCF) + CalciumExperimental Treatment1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group II: Soluble Corn Fiber (SCF) without calciumActive Control1 Intervention
This group will receive 12 g/d of soluble corn fiber (SCF) + 600 mg/d of elemental calcium carbonate, administered twice a day
Group III: PlaceboPlacebo Group1 Intervention
This group will receive a similar supplement without SCF or calcium, administered twice a day
Group IV: Placebo + calciumPlacebo Group1 Intervention
This group will receive a similar supplement without SCF + 600 mg/d of elemental calcium carbonate, administered twice a day

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
106 Previous Clinical Trials
18,700 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,633 Total Patients Enrolled
13 Trials studying Osteoporosis
4,151 Patients Enrolled for Osteoporosis
Cristina Palacios, PhDPrincipal Investigator - Department of Dietetics, College of Public Health, Florida International Univ.
Florida International University
2 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

Osteoporosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT02916862 — Phase 2
~26 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top