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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, 500 mg calcium | Placebo Comparator | Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks |
|
| 600 IU vitamin D + 500 mg calcium | Active Comparator | Participants received 600 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks |
|
| 1200 IU vitamin D + 500 mg calcium | Active Comparator | Participants received 1200 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks |
|
| 4000 IU vitamin D + 500 mg calcium | Active Comparator | Participants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo, 500 mg calcium | Dietary Supplement | Berry flavoured sachet powder (500 mg calcium) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 -80ËšC until sent for analysis | Baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 -80ËšC until sent for analysis | Baseline and week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geok Lin Khor | IMU University, Malaysia | Study Chair |
| Megan Chong | IMU University, Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | Kuala Lumpur | 57000 | Malaysia |
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
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 27, 2022 | Feb 26, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| 600 IU vitamin D + 500 mg calcium | Dietary Supplement | Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium) |
|
| 1200 IU vitamin D + 500 mg calcium | Dietary Supplement | Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium) |
|
| 4000 IU vitamin D + 500 mg calcium | Dietary Supplement | Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium) |
|
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |