Vitamin D Supplementation for Vitamin D Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the amount of vitamin D children need to stay healthy, particularly those with limited sunlight exposure. Vitamin D is essential for strong bones and a robust immune system. Children and teens weighing 140 pounds or more who are not currently taking vitamin D supplements may qualify. The trial involves administering vitamin D supplements based on weight to assess their health impact. As an unphased trial, this study provides a unique opportunity to enhance understanding of vitamin D requirements in children and teens.
What prior data suggests that this protocol is safe for children with Vitamin D deficiency?
Research has shown that taking vitamin D3 in doses of 2,000 to 4,000 IU per day is usually safe for most people. Most individuals experience no major side effects at these levels. However, excessive intake of vitamin D can be harmful. Staying within the recommended dose reduces the risk of negative effects. Overall, vitamin D supplements are considered safe for most people when taken in the right amounts.12345
Why are researchers excited about this trial?
Most treatments for vitamin D deficiency involve taking vitamin D supplements in standard doses, regardless of individual needs. However, the treatment being studied is unique because it tailors Vitamin D3 supplementation based on a patient's weight. This personalized approach could potentially optimize vitamin D levels more effectively and safely than traditional fixed-dose methods. Researchers are excited about this because it could lead to more precise treatment, reducing the risk of both under- and over-supplementation.
What evidence suggests that Vitamin D3 supplementation might be an effective treatment for Vitamin D deficiency?
Research has shown that vitamin D3 effectively raises vitamin D levels in the body. It increases calcium levels, strengthening bones and improving bone density in those with vitamin D deficiency. Vitamin D3 also proves more effective than vitamin D2 in building and maintaining healthy vitamin D levels. For children with low vitamin D, this can enhance bone growth and reduce the risk of fractures. Additionally, vitamin D aids the body in absorbing more calcium and phosphorus, essential for healthy bones.16789
Are You a Good Fit for This Trial?
This trial is for children in New Jersey who are otherwise healthy but may have vitamin D deficiency, especially those at higher risk due to limited sun exposure or larger body size. Children with certain health conditions or on medications that affect vitamin D levels may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vitamin D supplementation based on weight
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Calcium
- Vitamin C
- Vitamin D3
Trial Overview
The study tests a new method of giving daily vitamin D3 doses based on each child's weight, along with calcium and vitamin C supplements, to see how well it treats or prevents low vitamin D and related bone problems.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patient's are given supplementation based on weight. There is no placebo comparator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atlantic Health System
Lead Sponsor
Citations
Vitamin D Deficiency - StatPearls - NCBI Bookshelf
However, vitamin D3 is more effective in raising serum 25-hydroxyvitamin D levels.[32]. For a serum level below 12 ng/mL, initial ...
The health effects of vitamin D supplementation: evidence ...
These data indicate that correction of severe vitamin D deficiency might improve bone density, but not when given to vitamin D-replete people.
Vitamin D Deficiency and Related Disorders
Past studies suggested that vitamin D3 may be more effective than vitamin D2 in establishing normal vitamin D stores.
The Vitamin D Epidemic and its Health Consequences
A deficiency in vitamin D results in a decrease in the efficiency of intestinal absorption of dietary calcium and phosphorus (10,11,24). Although it is only 20 ...
Vitamin D - Health Professional Fact Sheet
No studies have examined whether such screening for vitamin D deficiency results in improved health outcomes [55].
Cholecalciferol (vitamin D3): efficacy, safety, and ...
Standard-dose vitamin D supplementation (2,000–4,000 IU/day) is generally considered safe and well-tolerated, with minimal risk of adverse effects. However, ...
Vitamin D
Taken in typical doses, vitamin D is thought to be mainly safe. But taking too much vitamin D in the form of supplements can be harmful and even ...
8.
health.harvard.edu
health.harvard.edu/diet-and-nutrition/taking-too-much-vitamin-d-can-cloud-its-benefits-and-create-health-risksTaking too much vitamin D can cloud its benefits and ...
Low blood levels of Vitamin D have been associated with higher risks of everything from heart disease, diabetes, and cancer to mood ...
Cholecalciferol Supplementation in Critically Ill Patients ...
A recent RCT has demonstrated 50% reduction in hospital mortality in patients with severe vit.D deficiency following a single high dose of cholecalciferol ( ...
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