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Not yet recruitingNCT07876843Updated Oct 20, 2026

The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.

An interventional study of Vitamin D3, Calcium, and Vitamin C in Hypovitaminosis D, sponsored by Atlantic Health System. Not yet recruiting at 1 site in United States. Open to participants aged 6 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Atlantic Health System · Not applicable, Interventional, and Supportive care

Updated Oct 20, 2026Eligibility revisedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
6 Years to 21 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypovitaminosis D

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03

In context

Vitamin D Deficiency

784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's planned enrollment of 200 is above the median of 77 across 574 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 21 Years
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.

Inclusion criteria

  • 6 to 21 years old (inclusive)
  • Patients 63.5 kg (140 lbs) and up
  • Patients not currently taking vitamin D supplements

Exclusion criteria

Exclusion Criteria:

  • 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 )
  • Kidney or Liver disease
  • Neuromuscular disease
  • Non-weight bearing patients
  • Malabsorption (Celiac disease, CF)
  • Already Taking vitamin D supplement
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Vitamin D supplementation

    Patient's are given supplementation based on weight. There is no placebo comparator

    Dietary Supplement: Vitamin D3, Calcium, and Vitamin C

Interventions

  • Dietary supplementVitamin D3, Calcium, and Vitamin C

    Vit D3- 5,000IU for subjects 140lbs-100lbs, Vit D3- 10,000IU for subjects 200+lbs Vit C- 500mg Calcium-1,000 mg

06

What researchers measure

Primary outcomes

  1. Measuring blood serum Vit D

    Serial labs for Vit D drawn to measure levels

    Time frame: Initial visit, 6 weeks, 5 months, 1 year

  2. Measuring blood calcium level

    Serial labs for calcium drawn to measure levels

    Time frame: Initial visit, 6 weeks, 5 months, 1 year

07

Study locations

1 site
  • Children's Orthopedic and Sports Medicine Center
    Morristown, New Jersey 07960, United States
08

Updates

2 registry updates since Sep 25, 2026
Also revised
eligibility, primary outcomes and interventions
Registered
First appeared on the registry
Oct 15, 2026
Show all 2 updates
  1. Oct 20, 2026
    Eligibility Criteria revised
    Primary outcomes Revised (3 changes)
    Interventions Arms or interventions changed
    + 1 other change: responsible party
  2. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07876843
Lead sponsor
Atlantic Health System
Responsible party
Barbara Minkowitz (Principal Investigator, Atlantic Health System) — Principal investigator
First posted
Oct 15, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Oct 20, 2026

Study contacts

Barbara Minkowitz, Medical Doctor- MD
Contact
barbara.minkowitz@atlantichealth.org
973-206-1033
Melissa M Lynch, Physician Assistant -PA
Contact
melissa.lynch@atlantichealth.org
973-206-1033

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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