NCT03864172

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

March 4, 2019

Last Update Submit

August 7, 2019

Conditions

Bone Health

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density ( BMD)

    BMD at total body and lumbar spine L1-L4

    12 months

  • Bone mineral content (BMC)

    BMC at total body and lumbar spine L1-L4

    12 months

Secondary Outcomes (1)

  • Bone biomarkers

    12 months

Study Arms (4)

Usual intake + placebo fruit juice

PLACEBO COMPARATOR

Placebo fruit flavoured juice powder

Dietary Supplement: Usual intake + placebo fruit juice

Usual intake +SCF fruit juice

ACTIVE COMPARATOR

Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF)

Dietary Supplement: Usual intake+SCF fruit juice

Adequate calcium +fruit juice placebo

ACTIVE COMPARATOR

Placebo fruit flavoured juice powder added with 600 mg calcium to meet RNI intake

Dietary Supplement: Adequate calcium + placebo fruit juice

Adequate calcium + SCF fruit juice

ACTIVE COMPARATOR

Fruit flavoured juice powder added with 12 g soluble corn fiber (SCF) and 600 mg calcium to meet RNI intake

Dietary Supplement: Adequate calcium+ SCF fruit juice

Interventions

Usual intake + placebo fruit juiceDIETARY_SUPPLEMENT

Participants will consume 200 mls of placebo fruit flavoured juice

Usual intake + placebo fruit juice
Usual intake+SCF fruit juiceDIETARY_SUPPLEMENT

Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)

Usual intake +SCF fruit juice
Adequate calcium + placebo fruit juiceDIETARY_SUPPLEMENT

Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI

Adequate calcium +fruit juice placebo
Adequate calcium+ SCF fruit juiceDIETARY_SUPPLEMENT

Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI

Adequate calcium + SCF fruit juice

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Screened to be generally healthy as determined by standard medical assessment on physical and mental health
  • Tanner stage 2 based on breast development for girls, and pubic hair in boys. Girls will have to be premenarcheal
  • Having obtained his/her informed consent and parents or legal guardians consent

You may not qualify if:

  • History of serious medical conditions such as intestinal or severe metabolic diseases, disorders such as diabetes, renal, hepatic or pancreatic diseases, disorders, ulcer, hyperthyroidism, malignance, chronic malnutrition, anaemia
  • History or on therapy with medication known to interfere with bone metabolism such as steroids, hormones, diuretics, cortisone or anti-seizure medication
  • Taking regularly any nutritional supplements and unwilling to stop for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Medical University

Kuala Lumpur, 57000, Malaysia

Location

Related Publications (1)

  • Arasu K, Chang CY, Wong SY, Ong SH, Yang WY, Chong MHZ, Mavinkurve M, Khoo EJ, Chinna K, Weaver CM, Chee WSS. 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). Osteoporos Int. 2023 Apr;34(4):783-792. doi: 10.1007/s00198-023-06702-0. Epub 2023 Feb 21.

    PMID: 36808216DERIVED

Study Officials

  • Winnie SS Chee, PhD

    IMU University, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

August 2, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)