Renal Insufficiency, ChronicNCT05165173
Almond Milk With Vitamin D: Impact on Vitamin D Status
A study testing NanoD4CKD and MicroD4CKD in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by University of Florida at 1 site in United States.
Trial summary
The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
- What is being tested?
- NanoD4CKD and MicroD4CKD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 18 Nov 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults who have been diagnosed with CKD
- have no GI disorders or GI disturbances
- age 18 years or older
- no food allergies or dietary restrictions
- all with no contraindications to consuming anything by mouth as per their physician
Who cannot join
- no diagnosis of CKD
- GI disorders
- gastrointestinal disturbances
- under 18 years old
- food allergies to almonds
- Dietary restrictions as medically indicated
- trouble chewing/swallowing as confirmed by physician
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.
- Being tested
- NanoD4CKD, MicroD4CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoD4CKDDietary supplement
Participants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of nanoparticles of D3 and instructed to consume it in the morning with a meal.
MicroD4CKDDietary supplement
Participants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of microparticles of D3 and instructed to consume it in the morning with a meal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Based on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group. Receives: Dietary Supplement: NanoD4CKD |
| Comparator | Active comparator | Based on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group. Receives: Dietary Supplement: MicroD4CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D
baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups.
Measured: 21 days
Secondary outcomes (6)
Calcium
baseline to end line in the concentration of serum calcium between and within the control and intervention groups.
Measured: 21 days
PTH
baseline to end line in the concentration of serum PTH between and within the control and intervention groups.
Measured: 21 days
parent vitamin D
baseline to end line in the concentration of serum parent vitamin D between and within the control and intervention groups.
Measured: 21 days
IL-6
baseline to end line in the concentration of serum IL-6 between and within the control and intervention groups.
Measured: 21 days
C-reactive protein
baseline to end line in the concentration of C-reactive protein between and within the control and intervention groups.
Measured: 21 days
TNF-alpha
baseline to end line in the concentration of serum TNF-alpha between and within the control and intervention groups.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start22 May 2023
- Primary completion18 Nov 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized comparator-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanette Andrade, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165173
- Sponsor's protocol ID
- IRB202102986
- Other IDs
- OCR41655
- Status last verified
- Jun 2024
- First submitted
- 17 Dec 2021
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almond Milk With Vitamin D: Impact on Vitamin D Status
- ClinicalTrials.gov ID
- NCT05165173
- Acronym / sponsor ID
- IRB202102986
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 18 Nov 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 21 Dec 2021 (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.
The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized comparator-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: NanoD4CKDBased on estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the nanoparticle group. |
| Comparator | Active comparator | Dietary Supplement: MicroD4CKDBased on the estimated glomerular filtration rate (eGFR) and vitamin D levels, participants will be placed into the microparticle group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults who have been diagnosed with CKD
- have no GI disorders or GI disturbances
- age 18 years or older
- no food allergies or dietary restrictions
- all with no contraindications to consuming anything by mouth as per their physician
Key exclusion criteria (7 listed)
- no diagnosis of CKD
- GI disorders
- gastrointestinal disturbances
- under 18 years old
- food allergies to almonds
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 |
|---|---|---|
| NanoD4CKDParticipants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of nanoparticles of D3 and instructed to consume it in the morning with a meal. | Dietary supplement | Intervention |
| MicroD4CKDParticipants will receive a 7-day supply of the 4-ounce almond milk mixed with 4000 IUs of microparticles of D3 and instructed to consume it in the morning with a meal. | Dietary supplement | Comparator |
Primary outcome
Vitamin D
Time frame: 21 days
baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups.
6 secondary outcomes
Calcium
Time frame: 21 days
PTH
Time frame: 21 days
parent vitamin D
Time frame: 21 days
IL-6
Time frame: 21 days
C-reactive protein
Time frame: 21 days
TNF-alpha
Time frame: 21 days
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 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Jeanette Andrade, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoD4CKD and MicroD4CKD in people with Renal Insufficiency, Chronic and Kidney Failure, Chronic, run by University of Florida at 1 site in United States.
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 5 inclusion and 7 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 10 Jun 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Vitamin D (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.