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NCT03864172: PREBONE-Kids

Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)

Completed NA Last updated 9 August 2019
What this trial tests

NA trial testing Usual intake + placebo fruit juice in Bone Health in 243 participants. Completed in 1 August 2019.

Timeline
2 August 2017
Primary endpoint
1 August 2019
1 August 2019

Quick facts

Lead sponsorIMU University, Malaysia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment243
Start date2 August 2017
Primary completion1 August 2019
Estimated completion1 August 2019
Sites1 location across Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

IMU University, Malaysia

Who can join

Adults 9 to 11, any sex, with Bone Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to investigate the effects of soluble corn fiber (SCF) on bone mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls. The hypothesis to be tested is: SCF will lead to greater increase of BMD, as measured with densitometry in both low calcium as well as high calcium intakes compared to placebo.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Vitamin D Status Is Associated with Modifiable Lifestyle Factors in Pre-Adolescent Children Living in Urban Kuala Lumpur, Malaysia.
    Chee WSS, Chang CY, Arasu K, Wong SY, et al · · 2021 · cited 10× · PMID 34202743 · DOI 10.3390/nu13072175
  2. Design and strategies used for recruitment and retention in a double blind randomized controlled trial investigating the effects of soluble corn fiber on bone indices in pre-adolescent children (PREBONE-Kids study) in Malaysia.
    Arasu K, Chang CY, Wong SY, Ong SH, et al · · 2021 · cited 8× · PMID 34195468 · DOI 10.1016/j.conctc.2021.100801
  3. Effect of soluble corn fibre and calcium supplementation on bone mineral content and bone mineral density in preadolescent Malaysian children-a double-blind randomised controlled trial (PREBONE-Kids Study).
    Arasu K, Chang CY, Wong SY, Ong SH, et al · · 2023 · cited 5× · PMID 36808216 · DOI 10.1007/s00198-023-06702-0
  4. Factors associated with bone health status of Malaysian pre-adolescent children in the PREBONE-Kids Study.
    Chang CY, Arasu K, Wong SY, Ong SH, et al · · 2021 · cited 2× · PMID 34479539 · DOI 10.1186/s12887-021-02842-6
  5. Bone mass, muscle-bone unit, and bone turnover markers in healthy preadolescent Malaysian children.
    Arasu K, Swee WCS, Weaver CM. · · 2025 · PMID 40460857 · DOI 10.6065/apem.2448232.116

Verify or expand the search:

Other recruiting trials for Bone Health

Currently open trials in the same condition.

Other IMU University, Malaysia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03864172.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing