NCT05281107

Vitamin D Supplementation and PTH Response Among Malaysian Adults

Vitamin D Supplementation, Parathyroid Hormone (PTH) and Plasma Vitamin D Response Among Malaysian Female Adults: Double Blinded, Randomised Clinical Trial of Efficacy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: IMU University, Malaysia · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo, 500 mg calcium	Berry flavoured sachet powder (500 mg calcium)
DIETARY_SUPPLEMENT	600 IU vitamin D + 500 mg calcium	Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
DIETARY_SUPPLEMENT	1200 IU vitamin D + 500 mg calcium	Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
DIETARY_SUPPLEMENT	4000 IU vitamin D + 500 mg calcium	Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)

Timeline

• Start date: 2015-07-10
• Primary completion: 2016-09-26
• Completion: 2016-10-01
• First posted: 2022-03-16
• Last updated: 2022-03-16

Locations

1 site across 1 country: Malaysia