Vitamin D Supplementation and PTH Response Among Malaysian Adults

Sponsor

International Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05281107

Collaborator

(none)

106

Enrollment

Location

Arms

14.8

Actual Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	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	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 10, 2015

Actual Primary Completion Date :

Sep 26, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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