Vitamin D Supplementation and PTH Response Among Malaysian Adults

NCT ID: NCT05281107

Last Updated: 2022-03-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-10

Study Completion Date

2016-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo, 500 mg calcium

Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Group Type PLACEBO_COMPARATOR

Placebo, 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (500 mg calcium)

600 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

1200 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

4000 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Placebo, 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (500 mg calcium)

600 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

1200 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

4000 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Placebo, 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (500 mg calcium)

600 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

1200 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

4000 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Placebo, 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (500 mg calcium)

600 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

1200 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

4000 IU vitamin D + 500 mg calcium

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

600 IU vitamin D + 500 mg calcium

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

Intervention Type DIETARY_SUPPLEMENT

1200 IU vitamin D + 500 mg calcium

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

Intervention Type DIETARY_SUPPLEMENT

4000 IU vitamin D + 500 mg calcium

Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* three major ethnic groups (Malay, Chinese, Indian)
* age 20-45 years

Exclusion Criteria

* any diseases or conditions that may affect vitamin D metabolism, such as diabetes, cardiovascular diseases, bone diseases, autoimmune diseases, had major gastrointestinal surgery and diagnosed primary hyperparathyroidism
* medications that might affect vitamin D metabolism, such as insulin, thiazide diuretics, prednisolone, biphosphonates, tamoxifen and phenytoin
* pregnant and lactating women
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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IMU University, Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Melissa Leong En Ying

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Malaysia

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IMU R 144/2014 - File II

Identifier Type: -

Identifier Source: org_study_id

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