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RecruitingNCT07791797PHAABSUpdated Sep 10, 2026

Supplementation Absorption Comparison

A Phase 4 interventional study of Aquacelle® Omega 3 and Comparator Omega 3 in Healthy Volunteer, sponsored by RDC Clinical Pty Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by RDC Clinical Pty Ltd · Phase 4, Interventional, and Other

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • absorption
  • vitamin D
  • omega-3
03

In context

Lead sponsor

RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.

Browse RDC Clinical Pty Ltd studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Part A:

Inclusion criteria

Inclusion Criteria:

  • Adults 18 years and older
  • Generally healthy
  • 18.5-29.9 kg/m2
  • Able to provide
  • Agree to not participate in another clinical trial while enrolled in this trial
  • Agree not to change current diet and/or exercise frequency or intensity during entire study period
  • Participant's ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points

Exclusion criteria

Exclusion Criteria:

  • 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 (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)
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>21 alcoholic drinks week)
  • Pregnant or lactating women
  • Allergic to any of the ingredients in enhanced or standard formula
  • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month (excluding RDC Clinical trials)
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  • Regular use within the past 4 weeks of supplements containing the trial product

Part B:

The above criteria apply, plus baseline serum 25(OH)D \<20.0 ng/mL (\<50.0 nm/L)

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Aquacelle® Omega 3

    Participants will have a single dose containing 315mg EPA and DHA.

    Dietary Supplement: Aquacelle® Omega 3

  • Active comparator
    Comparator Omega 3

    Participants will have a single dose containing 315mg EPA and DHA

    Dietary Supplement: Comparator Omega 3

  • Experimental
    Plexosome® Vitamin D3

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

    Dietary Supplement: Plexosome® Vitamin D3

  • Active comparator
    Comparator Vitamin D3

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

    Dietary Supplement: Comparator Vitamin D3

  • Experimental
    Plexosome® Vitamin D3 6 weeks

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

    Dietary Supplement: Plexosome® Vitamin D3 6 weeks

  • Active comparator
    Comparator Vitamin D3 6 weeks

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

    Combination Product: Comparator Vitamin D3 6 weeks

Interventions

  • Dietary supplementAquacelle® Omega 3

    Participants will consume 1 capsule containing 315mg EPA and DHA

    Also known as: Omega-3

  • Dietary supplementComparator Omega 3

    Participants will consume 1 capsule containing 315mg EPA and DHA

    Also known as: Omega-3

  • Dietary supplementPlexosome® Vitamin D3

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

    Also known as: Cholecalciferol, Vitamin D3

  • Dietary supplementComparator Vitamin D3

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

    Also known as: Cholecalciferol, Vitamin D3

  • Dietary supplementPlexosome® Vitamin D3 6 weeks

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

    Also known as: Cholecalciferol, Vitamin D3

  • Combination productComparator Vitamin D3 6 weeks

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

    Also known as: Cholecalciferol, Vitamin D3

06

What researchers measure

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

  5. Part A: Change and absolute Tmax (vitamin D)

    Change and absolute Tmax

    Time frame: Baseline to day 7

  6. Part A: Change and absolute Cmax (vitamin D)

    Change and absolute Cmax

    Time frame: Baseline to day 7

  7. Part A: Change and absolute Tmax (omega-3)

    Change and absolute Tmax

    Time frame: Baseline to day 2

  8. Part A: Change and absolute Cmax (omega-3)

    Change and absolute Cmax

    Time frame: Baseline to day 2

  9. Part A: Participant demographics

    Participant demographics

    Time frame: Baseline

  10. Part A: Tolerability

    Tolerability

    Time frame: Baseline to day 7

  11. Part A: Safety via AE monitoring

    Safety via AE monitoring

    Time frame: Baseline to day 7

  12. Part B: Change from baseline at week 6, standard vs enhanced formulation

    Change from baseline at week 6, standard vs enhanced formulation

    Time frame: Baseline to week 6

  13. Part B: Weekly 25(OH)D change

    Weekly 25(OH)D change

    Time frame: Baseline to week 6

  14. Part B: Weekly cholecalciferol change

    Weekly cholecalciferol change

    Time frame: Baseline to week 6

  15. Part B: Demographics

    Demographics

    Time frame: Baseline

  16. Part B: Tolerability

    Tolerability

    Time frame: Baseline to week 6

  17. Part B: Safety (E/LFT)

    Safety (E/LFT)

    Time frame: Baseline to week 6

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

  5. Part B (exploratory): interleukin-1b (IL-1b)

    Change from baseline to week 6 in interleukin-1b (IL-1b)

    Time frame: Baseline to week 6

  6. Part B (exploratory): MCP-1 (Monocyte Chemoattractant Protein-1)

    Change from baseline to week 6 in MCP-1 (Monocyte Chemoattractant Protein-1) also known as CCL2 (Chemokine (C-C motif) ligand 2)

    Time frame: Baseline to week 6

  7. Part B (exploratory): tumour necrosis factor-alpha (TNF-α)

    Change from baseline to week 6 in tumour necrosis factor-alpha (TNF-α)\].

    Time frame: Baseline to week 6

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

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 Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791797
Lead sponsor
RDC Clinical Pty Ltd
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Aug 31, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

David Briskey
Contact
research@rdcglobal.com.au
+61(0)731024486
David Briskey
principal investigator · RDC Clinical

Oversight

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

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Studies of the drugs tested here: Omega-3 fatty acid · Cholecalciferol

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