Vitamin D Supplementation and PTH Response Among Malaysian Adults
NCT ID: NCT05281107
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
106 participants
INTERVENTIONAL
2015-07-10
2016-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo, 500 mg calcium
Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
600 IU vitamin D + 500 mg calcium
Participants received 600 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Participants received 1200 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Participants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
Interventions
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Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
Eligibility Criteria
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Inclusion Criteria
* age 20-45 years
Exclusion Criteria
* medications that might affect vitamin D metabolism, such as insulin, thiazide diuretics, prednisolone, biphosphonates, tamoxifen and phenytoin
* pregnant and lactating women
20 Years
45 Years
FEMALE
Yes
Sponsors
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IMU University, Malaysia
OTHER
Responsible Party
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Melissa Leong En Ying
Principal Investigator
Principal Investigators
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Geok Lin Khor
Role: STUDY_CHAIR
IMU University, Malaysia
Megan Chong
Role: STUDY_DIRECTOR
IMU University, Malaysia
Locations
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International Medical University
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IMU R 144/2014 - File II
Identifier Type: -
Identifier Source: org_study_id
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