Vitamin D Supplementation and PTH Response Among Malaysian Adults

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: 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

• Registration Number: NCT05281107
• Lead Sponsor: International Medical University

Brief 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.

Study Timeline

• Study Start: 2015-07-10
• Primary Completion: 2016-09-26
• Study Completion: 2016-10-01
• Study First Submitted: 2022-02-28
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo, 500 mg calcium	Placebo, 500 mg calcium	Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
600 IU vitamin D + 500 mg calcium	4000 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
1200 IU vitamin D + 500 mg calcium	600 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
4000 IU vitamin D + 500 mg calcium	1200 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
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
Placebo, 500 mg calcium	1200 IU vitamin D + 500 mg calcium	Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
600 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
600 IU vitamin D + 500 mg calcium	Placebo, 500 mg calcium	Participants received 600 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
600 IU vitamin D + 500 mg calcium	1200 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
Placebo, 500 mg calcium	4000 IU vitamin D + 500 mg calcium	Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
Placebo, 500 mg calcium	600 IU vitamin D + 500 mg calcium	Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
1200 IU vitamin D + 500 mg calcium	Placebo, 500 mg calcium	Participants received 1200 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
1200 IU vitamin D + 500 mg calcium	4000 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
4000 IU vitamin D + 500 mg calcium	Placebo, 500 mg calcium	Participants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
1200 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
4000 IU vitamin D + 500 mg calcium	600 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

Primary Outcome Measures

Name	Time	Method
Change from baseline plasma 25-hydroxyvitamin D at week 16	Baseline and 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

Secondary Outcome Measures

Name	Time	Method
Change from baseline intact parathyroid hormone at week 16	Baseline and 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

Trial Locations

Locations (1)

International Medical University; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia