Vitamin D DeficiencyNCT06203041
Vitamin D Sulfates in Breastmilk
A study testing Vitamin D in people with Vitamin D Deficiency and Breast Milk Collection, run by Mayo Clinic at 1 site in United States.
Trial summary
Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut). Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in… Read more about this study
- Who is it for?
- Ages 1 month to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Breast Milk Collection
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 5 May 2026
- 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 1 month to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Lactating mothers
- ≥2 weeks after delivery
- No intentions of weaning during the study
- Female and male infants
- Exclusively breastfed
Who cannot join
- History of sarcoidosis
- History of renal disease
- Premature birth- <37 weeks
- Taking daily supplement with ≥600 IU vitamin D in the past 30 days
- Breastfeeding Infants
- No known gastrointestinal diseases that require medical treatment
- Currently prescribed antibiotics or have taken antibiotics <2 weeks from collection
Trial locations and contacts
1 site in 1 country.
About this study
Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut).
Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.
Read the detailed description
Infants
Sign the consent form to confirm participation:
You will be asked to bring a soiled diaper from the morning of the study visit. You will meet with a study team member who will collect up to 6 swabs total:
Up to 3 cheek/mouth swabs to collect saliva Up to 3 stool/anus/diaper swabs
Lactating Mothers
Sign the consent form to confirm participation:
Visit 1 (Baseline) You will meet with a study team member complete some demographic information and gestational age of the baby and birthdate, next you will have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will schedule visit 2. The study will provide the vitamin D supplement that you will take daily for 28 days.
Visit 2 (post intervention) Approximately 28 days later you will meet with a study team member, have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will ask for the container the Vitamin D supplement was in.
You have 2 options:
Option 1:
Bring along your personal breast pump and collection container to each study visit.
The study team member will collect up to 50 ml of freshly expressed breast milk for the study.
Option 2:
You do not bring along your personal breast pump and containers to each study visit, instead you will be asked to:
Manually express your breast milk into a specimen collection cup at each study visit.
- Conditions
- Vitamin D Deficiency, Breast Milk Collection
- Being tested
- Vitamin D
- Medical subject headings
- Vitamin D Deficiency, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called cholecalciferol
Orally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Lactating women | Experimental | Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days. Receives: Dietary Supplement: Vitamin D |
| Breastfeeding Infants | No intervention | No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vitamin D sulfate levels in breastmilk
Samples will be assessed using a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Measured: Baseline, Day 28
Secondary outcomes (2)
Vitamin D sulfate levels in infant saliva
Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Measured: Baseline
Vitamin D sulfate levels in infant digesta
Samples will first be assessed for activity using a general sulfatase activity assay, followed by a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start21 Nov 2023
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Thacher, Mayo Clinic
- Investigators
- Thomas Thatcher, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203041
- Sponsor's protocol ID
- 22-005324
- Status last verified
- May 2026
- First submitted
- 2 Jan 2024
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Sulfates in Breastmilk
- ClinicalTrials.gov ID
- NCT06203041
- Acronym / sponsor ID
- 22-005324
- Conditions
- Vitamin D Deficiency, Breast Milk Collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 12 Jan 2024 (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.
Infants The purpose of this study is to measure breastmilk's vitamin D sulfate nutritional value in infant's saliva and digesta (gut).
Breastfeeding Mothers The purpose of this study is to measure Vitamin D sulfates in freshly expressed breastmilk samples before and after 28 days of Vitamin D supplementation in lactating mothers.
Detailed description
Infants
Sign the consent form to confirm participation:
You will be asked to bring a soiled diaper from the morning of the study visit. You will meet with a study team member who will collect up to 6 swabs total:
Up to 3 cheek/mouth swabs to collect saliva Up to 3 stool/anus/diaper swabs
Lactating Mothers
Sign the consent form to confirm participation:
Visit 1 (Baseline) You will meet with a study team member complete some demographic information and gestational age of the baby and birthdate, next you will have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will schedule visit 2. The study will provide the vitamin D supplement that you will take daily for 28 days.
Visit 2 (post intervention) Approximately 28 days later you will meet with a study team member, have a blood draw and express breast milk in a private location, the study team will collect up to 50 ml of freshly expressed breast milk for the research study, you will be asked to bring your personal breast pump and collection container to each research visit, or manually express milk, see options below. The study team member will ask for the container the Vitamin D supplement was in.
You have 2 options:
Option 1:
Bring along your personal breast pump and collection container to each study visit.
The study team member will collect up to 50 ml of freshly expressed breast milk for the study.
Option 2:
You do not bring along your personal breast pump and containers to each study visit, instead you will be asked to:
Manually express your breast milk into a specimen collection cup at each study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactating women | Experimental | Dietary Supplement: Vitamin DSubjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days. |
| Breastfeeding Infants | No intervention | –No intervention will be administered. |
Who may qualify
- Ages
- 1 month to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Lactating mothers
- ≥2 weeks after delivery
- No intentions of weaning during the study
- Female and male infants
- Exclusively breastfed
Key exclusion criteria (7 listed)
- History of sarcoidosis
- History of renal disease
- Premature birth- <37 weeks
- Taking daily supplement with ≥600 IU vitamin D in the past 30 days
- Breastfeeding Infants
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 |
|---|---|---|
| Vitamin DAlso: cholecalciferolOrally administered, daily dose of 5000 IU (125 mcg) Vitamin D3 for 28 days. | Dietary supplement | Lactating women |
Primary outcome
Change in Vitamin D sulfate levels in breastmilk
Time frame: Baseline, Day 28
Samples will be assessed using a Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) assay on the Agilent 6490 tandem mass spectrometer instrument.
2 secondary outcomes
Vitamin D sulfate levels in infant saliva
Time frame: Baseline
Vitamin D sulfate levels in infant digesta
Time frame: Baseline
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 13 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Strategies for Proactive Health in People With Kidney Function Decline
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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.
Thomas Thatcher, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency and Breast Milk Collection, run by Mayo Clinic 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 13 May 2026. 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?
Change in Vitamin D sulfate levels in breastmilk (time frame: Baseline, Day 28). 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 13 May 2026.