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Completed

NCT Number: NCT05281107

Vitamin D Supplementation and PTH Response Among Malaysian Adults

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

International Medical University

Kuala Lumpur, 57000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo, 500 mg calcium

Dietary Supplement

Berry flavoured sachet powder (500 mg calcium)

600 IU vitamin D + 500 mg calcium

Dietary Supplement

Berry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)

1200 IU vitamin D + 500 mg calcium

Dietary Supplement

Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)

4000 IU vitamin D + 500 mg calcium

Dietary Supplement

Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)

Primary outcomes

  1. Change from baseline plasma 25-hydroxyvitamin D at week 16

    Time frame: 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 outcomes

  1. Change from baseline intact parathyroid hormone at week 16

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IMU University, Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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