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NCT03864172: PREBONE-Kids
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
NA trial testing Usual intake + placebo fruit juice in Bone Health in 243 participants. Completed in 1 August 2019.
1 August 2019
Quick facts
| Lead sponsor | IMU University, Malaysia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 243 |
| Start date | 2 August 2017 |
| Primary completion | 1 August 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 1 location across Malaysia |
Drugs / interventions tested
- Usual intake + placebo fruit juice
- Usual intake+SCF fruit juice
- Adequate calcium + placebo fruit juice
- Adequate calcium+ SCF fruit juice
Conditions studied
- Bone Health — all drugs for Bone Health →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03864172
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other IMU University, Malaysia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03864172 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IMU University, Malaysia
- Last refreshed: 9 August 2019
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