NCT05281107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Jul 2015

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

February 28, 2022

Last Update Submit

March 10, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline intact parathyroid hormone at week 16

    Baseline and week 16

Study Arms (4)

Placebo, 500 mg calcium

PLACEBO COMPARATOR

Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Dietary Supplement: Placebo, 500 mg calciumDietary Supplement: 600 IU vitamin D + 500 mg calciumDietary Supplement: 1200 IU vitamin D + 500 mg calciumDietary Supplement: 4000 IU vitamin D + 500 mg calcium

600 IU vitamin D + 500 mg calcium

ACTIVE COMPARATOR

Participants received 600 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Dietary Supplement: Placebo, 500 mg calciumDietary Supplement: 600 IU vitamin D + 500 mg calciumDietary Supplement: 1200 IU vitamin D + 500 mg calciumDietary Supplement: 4000 IU vitamin D + 500 mg calcium

1200 IU vitamin D + 500 mg calcium

ACTIVE COMPARATOR

Participants received 1200 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Dietary Supplement: Placebo, 500 mg calciumDietary Supplement: 600 IU vitamin D + 500 mg calciumDietary Supplement: 1200 IU vitamin D + 500 mg calciumDietary Supplement: 4000 IU vitamin D + 500 mg calcium

4000 IU vitamin D + 500 mg calcium

ACTIVE COMPARATOR

Participants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Dietary Supplement: Placebo, 500 mg calciumDietary Supplement: 600 IU vitamin D + 500 mg calciumDietary Supplement: 1200 IU vitamin D + 500 mg calciumDietary Supplement: 4000 IU vitamin D + 500 mg calcium

Interventions

Placebo, 500 mg calciumDIETARY_SUPPLEMENT

Berry flavoured sachet powder (500 mg calcium)

1200 IU vitamin D + 500 mg calcium4000 IU vitamin D + 500 mg calcium600 IU vitamin D + 500 mg calciumPlacebo, 500 mg calcium
600 IU vitamin D + 500 mg calciumDIETARY_SUPPLEMENT

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

1200 IU vitamin D + 500 mg calcium4000 IU vitamin D + 500 mg calcium600 IU vitamin D + 500 mg calciumPlacebo, 500 mg calcium
1200 IU vitamin D + 500 mg calciumDIETARY_SUPPLEMENT

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

1200 IU vitamin D + 500 mg calcium4000 IU vitamin D + 500 mg calcium600 IU vitamin D + 500 mg calciumPlacebo, 500 mg calcium
4000 IU vitamin D + 500 mg calciumDIETARY_SUPPLEMENT

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

1200 IU vitamin D + 500 mg calcium4000 IU vitamin D + 500 mg calcium600 IU vitamin D + 500 mg calciumPlacebo, 500 mg calcium

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • three major ethnic groups (Malay, Chinese, Indian)
  • age 20-45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Medical University

Kuala Lumpur, Kuala Lumpur, 57000, Malaysia

Location

MeSH Terms

Interventions

CalciumVitamin D

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Geok Lin Khor

    IMU University, Malaysia

    STUDY CHAIR

  • Megan Chong

    IMU University, Malaysia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 16, 2022

Study Start

July 10, 2015

Primary Completion

September 26, 2016

Study Completion

October 1, 2016

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

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

Locations

MY(1)