Hypovitaminosis DNCT07876843
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
A study testing Vitamin D3, Calcium, and Vitamin C in people with Hypovitaminosis D, run by Atlantic Health System at 1 site in United States.
Trial summary
Vitamin D is essential for calcium absorption and bone growth, brain development, and immune system function. Vitamin D is produced by the body in response to natural sunlight. In New Jersey, which is not near the equator and where children are indoors for large parts of the year or use of sun block, it is possible… Read more about this study
- Who is it for?
- Ages 6 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Vitamin D3, Calcium, and Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6 to 21 years old (inclusive)
- Patients 63.5 kg (140 lbs) and up
- Patients not currently taking vitamin D supplements
Who cannot join
- History of immunomodulation medication or immune deficiency disease
- History of immune incompetence (does not include diabetes)
- Sickle Cell Disease
- Cancer
- Chronic illness with decreased ambulation or non-ambulatory
- Taking medication that blocks absorption of vitamin D metabolism (glucocorticoids, antiseizure meds, antifungals, antifungals, cholestyramine, antacids and PPI )
Show all 11Show fewer
- Kidney or Liver disease
- Neuromuscular disease
- Non-weight bearing patients
- Malabsorption (Celiac disease, CF)
- Already Taking vitamin D supplement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Orthopedic and Sports Medicine Center
Morristown, New Jersey, 07960
About this study
Official title: A Method of Dosing Vitamin D by Weight
Vitamin D is essential for calcium absorption and bone growth, brain development, and immune system function. Vitamin D is produced by the body in response to natural sunlight. In New Jersey, which is not near the equator and where children are indoors for large parts of the year or use of sun block, it is possible that otherwise healthy children may suffer from vitamin D deficiency, placing them at risk for weak bones, fractures and poor bone growth. Larger children are at a higher risk of deficiency. This research is being conducted to identify children in this group with Vitamin D deficiency and determine the amount of vitamin D supplementation necessary for them daily using a protocol developed.
- Conditions
- Hypovitaminosis D
- Being tested
- Vitamin D3, Calcium, and Vitamin C
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3, Calcium, and Vitamin CDietary supplement
Vit D3- 5,000IU for subjects 140lbs-100lbs, Vit D3- 10,000IU for subjects 200+lbs Vit C- 500mg Calcium-1,000 mg
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | Patient's are given supplementation based on weight. There is no placebo comparator Receives: Dietary Supplement: Vitamin D3, Calcium, and Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring blood serum Vit D
Serial labs for Vit D drawn to measure levels
Measured: Initial visit, 6 weeks, 5 months, 1 year
Measuring blood calcium level
Serial labs for calcium drawn to measure levels
Measured: Initial visit, 6 weeks, 5 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Minkowitz, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876843
- Sponsor's protocol ID
- 1928169
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method of Dosing Vitamin D by Weight
- ClinicalTrials.gov ID
- NCT07876843
- Acronym / sponsor ID
- 1928169
- Conditions
- Hypovitaminosis D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 15 Oct 2026 (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.
Vitamin D is essential for calcium absorption and bone growth, brain development, and immune system function. Vitamin D is produced by the body in response to natural sunlight. In New Jersey, which is not near the equator and where children are indoors for large parts of the year or use of sun block, it is possible that otherwise healthy children may suffer from vitamin D deficiency, placing them at risk for weak bones, fractures and poor bone growth. Larger children are at a higher risk of deficiency. This research is being conducted to identify children in this group with Vitamin D deficiency and determine the amount of vitamin D supplementation necessary for them daily using a protocol developed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Dietary Supplement: Vitamin D3, Calcium, and Vitamin CPatient's are given supplementation based on weight. There is no placebo comparator |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6 to 21 years old (inclusive)
- Patients 63.5 kg (140 lbs) and up
- Patients not currently taking vitamin D supplements
Key exclusion criteria (11 listed)
- History of immunomodulation medication or immune deficiency disease
- History of immune incompetence (does not include diabetes)
- Sickle Cell Disease
- Cancer
- Chronic illness with decreased ambulation or non-ambulatory
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 D3, Calcium, and Vitamin CVit D3- 5,000IU for subjects 140lbs-100lbs, Vit D3- 10,000IU for subjects 200+lbs Vit C- 500mg Calcium-1,000 mg | Dietary supplement | Vitamin D supplementation |
Primary outcome
Measuring blood serum Vit D
Time frame: Initial visit, 6 weeks, 5 months, 1 year
Serial labs for Vit D drawn to measure levels
Measuring blood calcium level
Time frame: Initial visit, 6 weeks, 5 months, 1 year
Serial labs for calcium drawn to measure levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
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 D3, Calcium, and Vitamin C in people with Hypovitaminosis D, run by Atlantic Health System 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Minkowitz, Medical Doctor- MD (973-206-1033, barbara.minkowitz@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring blood serum Vit D (time frame: Initial visit, 6 weeks, 5 months, 1 year). The study lists 2 primary outcomes in all. 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 20 Oct 2026.