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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo, 500 mg calcium; Dietary supplement: 600 IU vitamin D + 500 mg calcium; Dietary supplement: 1200 IU vitamin D + 500 mg calcium; Dietary supplement: 4000 IU vitamin D + 500 mg calcium

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 57000
      • International Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo, 500 mg calcium; Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks	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)
Active Comparator: 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	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)
Active Comparator: 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	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)
Active Comparator: 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 -80˚C until sent for analysis	Baseline and week 16

Secondary Outcome Measures

Outcome Measure	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 -80˚C until sent for analysis	Baseline and week 16

Collaborators and Investigators

• Sponsor: International Medical University
• Investigators: Study Chair: Geok Lin Khor, International Medical University; Study Director: Megan Chong, International Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2015
• Primary Completion (Actual): September 26, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols
• Other Study ID Numbers: IMU R 144/2014 - File II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No