Health TrialsbyHealthPanel

Supplementation Absorption Comparison

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRDC Clinical Pty Ltd

About this trial

The goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults 18 years and older

Generally healthy

BMI 18.5-29.9 kg/m2

Able to provide informed consent

Disqualifiers

Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions

Have an unstable illness e.g. diabetes and thyroid gland dysfunction

Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years

Significant change in diet in the past 1-month (e.g., removal of a food group or calorie restriction)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aquacelle® Omega 3

    Dietary supplement

    Participants will consume 1 capsule containing 315mg EPA and DHA

  • Comparator Omega 3

    Dietary supplement

    Participants will consume 1 capsule containing 315mg EPA and DHA

  • Plexosome® Vitamin D3

    Dietary supplement

    Participants will have 1000IU vitamin D3 each day for 7 days

  • Comparator Vitamin D3

    Dietary supplement

    Participants will have 1000IU vitamin D3 each day for 7 days

  • Plexosome® Vitamin D3 6 weeks

    Dietary supplement

    Participants will have 1000IU vitamin D3 each day for 6 weeks

  • Comparator Vitamin D3 6 weeks

    Combination product

    Participants will have 1000IU vitamin D3 each day for 6 weeks

Treatment groups

160 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Aquacelle® Omega 3Experimental treatment 1 intervention
Group B: Comparator Omega 3Active comparator 1 intervention
Group C: Plexosome® Vitamin D3Experimental treatment 1 intervention
Group D: Comparator Vitamin D3Active comparator 1 intervention
Group E: Plexosome® Vitamin D3 6 weeksExperimental treatment 1 intervention
Group F: Comparator Vitamin D3 6 weeksActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)

Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t168 (vitamin D3)

Time frame
Baseline to day 7
2

Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)

Baseline-corrected values in serum/plasma absorption (AUC) of the trial product t0-t24 (omega-3)

Time frame
Baseline to day 2
3

Part B: Baseline-corrected serum 25(OH)D AUC (0-6 weeks)

Baseline-corrected serum 25(OH)D AUC (0-6 weeks)

Time frame
Baseline to 6 weeks

Secondary outcomes

1

Part A: Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)

Serum/plasma absorption (AUC) of the trial product t0-t8 (vitamin D3)

Time frame
Baseline to 8 hours
2

Part A: serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)

serum/plasma absorption (AUC) of the trial product t0-t24 (vitamin D3)

Time frame
Baseline to day 2
3

Part A: Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)

Serum/plasma absorption (AUC) of the trial product t0-t48 (vitamin D3)

Time frame
Baseline to day 3
4

Part A: Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)

Serum/plasma absorption (AUC) of the trial product t0-t10 (omega-3)

Time frame
Baseline to 10hours

Other outcomes

1

Part B (exploratory): parathyroid hormone

Change from baseline to week 6 in parathyroid hormone (PTH)

Time frame
Baseline to week 6
2

Part B (exploratory): calcium

Change from baseline to week 6 in calcium

Time frame
Baseline to week 6
3

Part B (exploratory): high-sensitivity C-reactive protein

Change from baseline to week 6 in high-sensitivity C-reactive protein (hs-CRP)

Time frame
Baseline to week 6
4

Part B (exploratory): interleukin-6 (IL-6)

Change from baseline to week 6 in interleukin-6 (IL-6)

Time frame
Baseline to week 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RDC Clinical Pty Ltd

Lead sponsor

Source ClinicalTrials.gov
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