HealthyEarly Phase 1NCT05281107

Vitamin D Supplementation and PTH Response Among Malaysian Adults

A Early Phase 1 study testing 600 IU vitamin D + 500 mg calcium, 1200 IU vitamin D + 500 mg calcium and 4000 IU vitamin D + 500 mg calcium in people with Healthy, run by IMU University, Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 600 IU vitamin D + 500 mg calcium, 1200 IU vitamin D + 500 mg calcium and 4000 IU vitamin D + 500 mg calcium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 1 siteMalaysia
Study dates: 10 Jul 2015to 1 Oct 2016
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

International Medical University
Kuala Lumpur, Kuala Lumpur, 57000

Other trials in Malaysia

About this study

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

Read the 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.

Conditions: Healthy
Being tested: Placebo, 500 mg calcium, 600 IU vitamin D + 500 mg calcium, 1200 IU vitamin D + 500 mg calcium, 4000 IU vitamin D + 500 mg calcium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo, 500 mg calciumDietary supplement
Berry flavoured sachet powder (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 calciumDietary supplement
Berry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)
4000 IU vitamin D + 500 mg calciumDietary supplement
Berry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)

Study groups in NCT05281107
Study group	Role	What they receive
Placebo, 500 mg calcium	Placebo comparator	Participants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks Receives: 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
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 Receives: 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
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 Receives: 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
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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and week 16

Secondary outcomes (1)

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
Measured: Baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20151 Oct 2016

First posted16 Mar 2022
Study start10 Jul 2015
Primary completion26 Sep 2016
Study completion1 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05281107
Sponsor's protocol ID: IMU R 144/2014 - File II
Status last verified: Mar 2022
First submitted: 28 Feb 2022
Last updated: 16 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D Supplementation, Parathyroid Hormone (PTH) and Plasma Vitamin D Response Among Malaysian Female Adults: Double Blinded, Randomised Clinical Trial of Efficacy
ClinicalTrials.gov ID: NCT05281107
Acronym / sponsor ID: IMU R 144/2014 - File II
Conditions: Healthy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: IMU University, MalaysiaUniversity, hospital or other
Study start: 10 Jul 2015 (actual)
Primary completion: 26 Sep 2016 (actual)
Study completion: 1 Oct 2016 (actual)
First posted: 16 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo, 500 mg calcium	Placebo comparator	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 calciumParticipants received 500 mg calcium in berry flavoured sachet powder daily for 16 weeks
600 IU vitamin D + 500 mg calcium	Active comparator	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 calciumParticipants 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	Active comparator	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 calciumParticipants 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	Active comparator	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 calciumParticipants received 4000 IU vitamin D with 500 mg calcium in berry flavoured sachet powder daily for 16 weeks

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo, 500 mg calciumBerry flavoured sachet powder (500 mg calcium)	Dietary supplement	1200 IU vitamin D + 500 mg calcium, 4000 IU vitamin D + 500 mg calcium, 600 IU vitamin D + 500 mg calcium, Placebo, 500 mg calcium
600 IU vitamin D + 500 mg calciumBerry flavoured sachet powder (600 IU vitamin D + 500 mg calcium)	Dietary supplement	1200 IU vitamin D + 500 mg calcium, 4000 IU vitamin D + 500 mg calcium, 600 IU vitamin D + 500 mg calcium, Placebo, 500 mg calcium
1200 IU vitamin D + 500 mg calciumBerry flavoured sachet powder (1200 IU vitamin D + 500 mg calcium)	Dietary supplement	1200 IU vitamin D + 500 mg calcium, 4000 IU vitamin D + 500 mg calcium, 600 IU vitamin D + 500 mg calcium, Placebo, 500 mg calcium
4000 IU vitamin D + 500 mg calciumBerry flavoured sachet powder (4000 IU vitamin D + 500 mg calcium)	Dietary supplement	1200 IU vitamin D + 500 mg calcium, 4000 IU vitamin D + 500 mg calcium, 600 IU vitamin D + 500 mg calcium, Placebo, 500 mg calcium

Primary outcome

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

1 secondary outcome

Change from baseline intact parathyroid hormone at week 16
Time frame: Baseline and week 16

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Individual participant dataSharing planned: No. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Geok Lin Khor study chair

IMU University, Malaysia

Megan Chong study director

IMU University, Malaysia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline plasma 25-hydroxyvitamin D at week 16 (time frame: Baseline and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05281107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.