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

NCT07876843 | Not Yet Recruiting DMC

• 1 other identifier: 1928169
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypovitaminosis D

Outcome Measures

Primary Outcomes (1)

• Measuring serum Vit D and Calcium following supplementation

  Serial labs for Vit D and Calcium drawn to measure levels

  Initial visit, 6 weeks, 5 months, 1 year

Study Arms (1)

1

OTHER

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

Dietary Supplement: Vitamin D3, Calcium, and Vitamin C

Interventions

Vitamin D3, Calcium, and Vitamin C DIETARY_SUPPLEMENT

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

1

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 6 to 21 years old (inclusive) 2. Patients 63.5 kg (140 lbs) and up 3. Patients not currently taking vitamin D supplements

You may not qualify if:

• \. History of immunomodulation medication or immune deficiency disease 2. History of immune incompetence (does not include diabetes) 3. Sickle Cell Disease 4. Cancer 5. Chronic illness with decreased ambulation or non-ambulatory 6. Taking medication that blocks absorption of vitamin D metabolism (glucocorticoids, antiseizure meds, antifungals, antifungals, cholestyramine, antacids and PPI ) 7. Kidney or Liver disease 8. Neuromuscular disease 9. Non-weight bearing patients 10. Malabsorption (Celiac disease, CF) 11. Already Taking vitamin D supplement

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Children's Orthopedic and Sports Medicine Center

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Calcium; Ascorbic Acid

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Barbara Minkowitz, Medical Doctor- MD

CONTACT

973-206-1033; barbara.minkowitz@atlantichealth.org

Melissa M Lynch, Physician Assistant -PA

CONTACT

973-206-1033; melissa.lynch@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2032
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

US (1)