Vitamin D Supplementation and PTH Response Among Malaysian Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281107
• Other study ID #: IMU R 144/2014 - File II
• Status: Completed
• Phase: Early Phase 1
• Start date: July 10, 2015
• Est. completion date: October 1, 2016

Study information

• Verified date: March 2022
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 1, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Placebo, 500 mg calcium
Berry flavoured sachet powder (500 mg calcium)
• 600 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)
• 1200 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
• 4000 IU vitamin D + 500 mg calcium
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)

Locations

Country	Name	City	State
Malaysia	International Medical University	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
International Medical University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and week 16
Secondary	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	Baseline and week 16