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RecruitingNCT06372158Updated Apr 17, 2024

Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism

An interventional study of Stage 1 and Stage 2 in Osteoporosis, sponsored by National Yang Ming Chiao Tung University. Recruiting at 2 sites in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements.

02

Conditions studied

  • Osteoporosis

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03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 20 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 201 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.

Exclusion criteria

Exclusion Criteria:

  1. Patients with renal insufficiency and dialysis
  2. Cancer patients
  3. Underweight (BMI#17) or obese (BMI#27)
  4. Those taking medications for chronic diseases
  5. Blood pressure systolic blood pressure # 130 mmHg or diastolic blood pressure # 85 mmHg
  6. Fasting blood glucose # 100 mg/dL
  7. Fasting triglycerides # 150 mg/dL, total cholesterol # 200 mg/dL
  8. Have a history of vitamin C allergy
  9. People suffering from mental illness
  10. Pregnant and breastfeeding women
  11. Patients with hemosiderosis
  12. Kidney stone patients
  13. Supplements for those who take calcium for a long time
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Stage 1

    Day 14

    Dietary Supplement: Stage 1

  • Other
    Stage 2

    Day 28

    Dietary Supplement: Stage 2

Interventions

  • Dietary supplementStage 1

    Number 1-10 :General vitamin C powder group (Contains 1500 mg Ca); Number 11-20: liposomal encapsulation Ca powder group (Contains 1500 mg of Ca and lecithin and is coated)

  • Dietary supplementStage 2

    Number 11-20 :General vitamin C powder group (Contains 1500 mg Ca); Number 1-10: liposomal encapsulation Ca powder group (Contains 1500 mg of Ca and lecithin and is coated)

06

What researchers measure

Primary outcomes

  1. General examination

    BMI(Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared) and blood pressure

    Time frame: Day 14 and 28

  2. Hematology Test

    Fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine(Blood urea nitrogen (BUN) and creatinine tests can be used together to find the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help your doctor check for problems, such as dehydration, that may cause abnormal BUN and creatinine levels.), GOT, GPT

    Time frame: Day 14 and 28

07

Study locations

2 of 2 sites recruiting
  • National Yang Ming Chiao Tung University
    Taipei, Beitou Dist. 112, Taiwan
    Recruiting
  • National Yang Ming Chiao Tung University
    Taipei, 112, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06372158
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
YenPing, Lei (Assistant professor, National Yang Ming Chiao Tung University) — Principal investigator
First posted
Apr 17, 2024
Start date
Apr 8, 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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