UVB treatment for Vitamin D Deficiency

Phase-Based Estimates
1
Effectiveness
1
Safety
BU School of Medicine, Boston, MA
+1 More
UVB treatment - Device
Eligibility
18+
All Sexes
Eligible conditions
Vitamin D Deficiency

Study Summary

Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status

See full description

Eligible Conditions

  • Vitamin D Deficiency
  • Vitamin D Insufficiency

Treatment Effectiveness

Study Objectives

This trial is evaluating whether UVB treatment will improve 9 primary outcomes in patients with Vitamin D Deficiency. Measurement will happen over the course of Week 1 post-intervention.

Baseline
Baseline serum 25-hydroxyvitamin D
Week 1 post-intervention
Serum 25-hydroxyvitamin D at 1 week post-intervention
Week 12
Serum 25-hydroxyvitamin D at 12 weeks of intervention
Week 16
Serum 25-hydroxyvitamin D at 16 weeks of intervention
Week 2 post-intervention
Serum 25-hydroxyvitamin D at 2 weeks post-intervention
Week 3 post-intervention
Serum 25-hydroxyvitamin D at 3 weeks post-intervention
Week 4
Serum 25-hydroxyvitamin D at 4 weeks of intervention
Week 4 post-intervention
Serum 25-hydroxyvitamin D at 4 weeks post-intervention
Week 8
Serum 25-hydroxyvitamin D at 8 weeks of intervention

Trial Safety

Trial Design

2 Treatment Groups

Sham comparator arm
UVB treatment arm
Placebo group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. UVB Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

UVB treatment arm
Device
The treatment group will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System UVB using the device titration system for the first 5 weeks. Once determined after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation.
Sham comparator arm
Device
The sham comparator group will undergo the procedures as the treatment group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UVB treatment
2011
Completed Phase 3
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 of the intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 12 of the intervention for reporting.

Closest Location

BU School of Medicine - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age at least 18 years' old
Male or Female
Skin Type I-VI
Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
Ability and Willingness to give informed consent and comply to protocol requirements
Serum total 25(OH)D < 30 ng/mL at the screening

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is vitamin d deficiency?

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Vitamin d deficiency is very common throughout the world with the highest prevalence in Europe, North America and South America. Vitamin D deficiency correlates with lower bone mineral density, osteopenia, osteoporosis, and increased fractures.

Unverified Answer

What are common treatments for vitamin d deficiency?

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Vitamin D supplementation alone, and with oral cholecalciferol, is an effective treatment to correct hypovitaminosis D. Treatment is typically given for six months, and the dosage can be adjusted based on a person's actual baseline vitamin D levels and body surface area. Alternative drugs, such as intravenous calcitriol and the bisphosphonate paricalcitol are no longer recommended. When possible and appropriate, sunflower oil can be used as a dietary source for vitamin D. In infants with vitamin D deficiency, supplementation with high-dose vitamin D is used as a therapeutic protocol.

Unverified Answer

Can vitamin d deficiency be cured?

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Vitamin d deficiency is rare and may be a secondary cause of many chronic medical conditions. Supplementation may play an important role in achieving an optimal body calcium status. We speculate whether a low body calcium/high vitamin D status ratio may contribute to the formation of tumours as well as to osteoporosis and other vitamin D-related disorders of bones.

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What causes vitamin d deficiency?

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Vitamin D deficiency is not only much more common in those living in northern latitude countries than in more northern countries, but also has a lower socioeconomic status, while solar exposure increases vitamin D levels. Sun exposure increases vitamin D levels in urban areas, while darkness contributes to deficiency in rural areas. Knowledge of vitamin D and its role is important, since vitamin D deficiency can have a significant impact on the body.

Unverified Answer

How many people get vitamin d deficiency a year in the United States?

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There is considerable variability based on race and socioeconomic status in the prevalence of vitamin D deficiency among US populations. Strategies that aim to increase vitamin D status in adults and children are needed in the United States; furthermore, additional research is warranted to evaluate the role of vitamin D deficiency in disease outcomes among diverse racial and ethnic populations.

Unverified Answer

What are the signs of vitamin d deficiency?

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In this population of community-dwelling adults, we found an association of vitamin D deficiency with higher serum bilirubin levels and a higher prevalence of some signs of osteoporosis, which was not reported previously.

Unverified Answer

What does uvb treatment usually treat?

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Diseases associated with vitamin D deficiency, such as rickets, osteomalacia, and CVD, are managed more efficiently and less expensively by ultraviolet B than by vitamin and dietary D. Therefore, use of an affordable, simple, and safe method of UVB therapy is essential for treating diseases that are associated with vitamin D deficiency.

Unverified Answer

What is the average age someone gets vitamin d deficiency?

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The National Health and Nutrition Examination Survey has found average U.S. vitamin D levels are 10 ng/mL (40.7 nmol/L) for children and 23 ng/mL (89.2 nmol/L) for adults; these are below recommendations, defined as 25(OH)D levels of 30 ng/mL (103 nmol/L) for children and 75 ng/mL (240 nmol/L) for adult level. However, these levels differ by racial and ethnic groups. For U.S. adults born in 1945 to 1964, the median and mean ages at 25(OH)D deficiency are 25.6 µg/mL (8.

Unverified Answer

What are the latest developments in uvb treatment for therapeutic use?

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Uvb treatment using high and low flux systems is rapidly becoming widely available. While more research is needed to assess its efficacy and safety, uvb is currently considered as one of the better options to treat photodamage due to its non-toxic effects and excellent cosmetic results.

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What is uvb treatment?

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Oral administration of 1-alpha and 25-dihydroxyvitamin D3 can increase serum concentrations of 25-hydroxyvitamin D at a dose of a few hundred thousand IU/day for patients with primary hyperparathyroidism. However, there is no benefit as far as the occurrence of fracture is concerned. On the other hand, there are no differences in the prevalence of bone turnover between the patients treated with high-dose 1-alpha and 25-dihydroxyvitamin D3 and those at the usual dose of 1,000 IU/day of vitamin D for the purpose of fracture prevention.

Unverified Answer

What is the primary cause of vitamin d deficiency?

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Vitamin d deficiency is prevalent in patients from the University of North Carolina at Charlotte's outpatient clinic for chronic rhinosinusitis with nasal polyps. More research on the etiologies, risks, and treatment modalities for vitamin D deficiency in nonmedical populations is needed.

Unverified Answer

Does uvb treatment improve quality of life for those with vitamin d deficiency?

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Significant changes occurred in the quality of sleep, the number of hours spent sleeping, and the duration of sleep after a treatment of 12 months with Uvb. Future studies are needed to evaluate the relationship between quality of sleep, fatigue, and pain/anxiety to determine the potential role of Uvb in these diseases.

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