An Early Phase 1 interventional study of Placebo, 500 mg calcium and 600 IU vitamin D + 500 mg calcium in Healthy, sponsored by International Medical University. Completed at 1 site in Malaysia. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by International Medical University · Early Phase 1, Interventional, and Basic science
This clinical trial was designed to determine the efficacy of vitamin D supplementation on plasma 25-hydroxyvitamin D [25(OH)D] and intact parathyroid hormone (PTH) concentrations of Malaysian female adults of child-bearing age after daily intake of vitamin D supplements containing either 0 IU, 600 IU, 1200 IU or 4000 IU vitamin D for 16 weeks.
After being informed regarding the study protocol and requirements, participants given informed consent were interviewed using a questionnaire for collection of background data and medical history as a screening process. Eligible participants were randomly assigned in a double-blind manner to receive daily 500 mg of calcium with either 0, 600 IU, 1200 IU or 4000 IU vitamin D supplement for 16 weeks. Questionnaires and anthropometric measurements were collected at baseline and post 16 weeks supplementation trial. Primary outcomes of plasma 25(OH)D and intact PTH were measured via fasting intravenous blood samples at baseline and post 16 weeks trial.
International Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Dietary Supplement: Placebo, 500 mg calcium · Dietary Supplement: 600 IU vitamin D + 500 mg calcium · Dietary Supplement: 1200 IU vitamin D + 500 mg calcium · Dietary Supplement: 4000 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
Dietary Supplement: Placebo, 500 mg calcium · Dietary Supplement: 600 IU vitamin D + 500 mg calcium · Dietary Supplement: 1200 IU vitamin D + 500 mg calcium · Dietary Supplement: 4000 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
Dietary Supplement: Placebo, 500 mg calcium · Dietary Supplement: 600 IU vitamin D + 500 mg calcium · Dietary Supplement: 1200 IU vitamin D + 500 mg calcium · Dietary Supplement: 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
Dietary Supplement: Placebo, 500 mg calcium · Dietary Supplement: 600 IU vitamin D + 500 mg calcium · Dietary Supplement: 1200 IU vitamin D + 500 mg calcium · Dietary Supplement: 4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)
Change from baseline plasma 25-hydroxyvitamin D at week 16
5ml of fasting blood sample were taken by venepuncture into heparin tubes. Collected blood samples were centrifuged at 4000 rpm for 10 minutes, extracted plasma and stored at -80˚C until sent for analysis
Time frame: Baseline and week 16
Change from baseline intact parathyroid hormone at week 16
5ml of fasting blood sample were taken by venepuncture into heparin tubes. Collected blood samples were centrifuged at 4000 rpm for 10 minutes, extracted plasma and stored at -80˚C until sent for analysis
Time frame: Baseline and week 16
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data cannot be shared publicly because of shared IPs. Data are available from the International Medical University Institutional Data Access (contact via khor.geoklin@gmail.com) for researchers who meet the criteria for access to confidential data
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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