Vitamin D Supplementation and PTH Response Among Malaysian Adults

International Medical University

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Placebo, 500 mg calcium; Dietary Supplement: 4000 IU vitamin D + 500 mg calcium; Dietary Supplement: 600 IU vitamin D + 500 mg calcium; Dietary Supplement: 1200 IU vitamin D + 500 mg calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT05281107

IMU R 144/2014 - File II

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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106 participants in 4 patient groups, including a placebo group

Placebo, 500 mg calcium

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: 600 IU vitamin D + 500 mg calcium

Dietary Supplement: 1200 IU vitamin D + 500 mg calcium

Dietary Supplement: Placebo, 500 mg calcium

Dietary Supplement: 4000 IU vitamin D + 500 mg calcium

600 IU vitamin D + 500 mg calcium

Active Comparator group

Description:

Participants received 600 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Treatment:

Dietary Supplement: 600 IU vitamin D + 500 mg calcium

Dietary Supplement: 1200 IU vitamin D + 500 mg calcium

Dietary Supplement: Placebo, 500 mg calcium

Dietary Supplement: 4000 IU vitamin D + 500 mg calcium

1200 IU vitamin D + 500 mg calcium

Active Comparator group

Description:

Participants received 1200 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Treatment:

Dietary Supplement: 600 IU vitamin D + 500 mg calcium

Dietary Supplement: 1200 IU vitamin D + 500 mg calcium

Dietary Supplement: Placebo, 500 mg calcium

Dietary Supplement: 4000 IU vitamin D + 500 mg calcium

4000 IU vitamin D + 500 mg calcium

Active Comparator group

Description:

Participants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Treatment:

Dietary Supplement: 600 IU vitamin D + 500 mg calcium

Dietary Supplement: 1200 IU vitamin D + 500 mg calcium

Dietary Supplement: Placebo, 500 mg calcium

Dietary Supplement: 4000 IU vitamin D + 500 mg calcium