Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) for Vitamin D Deficiency

Phase-Based Estimates
1
Effectiveness
1
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Vitamin D Deficiency+1 More
Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) - DietarySupplement
Eligibility
Any Age
All Sexes
Eligible conditions
Vitamin D Deficiency

Study Summary

This study is evaluating whether a new form of vitamin D may help improve vitamin D levels in individuals who have undergone a stem cell transplant.

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Eligible Conditions

  • Vitamin D Deficiency
  • Hematopoietic Stem Cell Transplantation (SCT)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) will improve 1 primary outcome in patients with Vitamin D Deficiency. Measurement will happen over the course of 12 weeks from starting vitamin D supplementation.

Week 12
Vitamin D Level

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Vitamin D Oral Thin Film (OTF)

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Vitamin D Oral Thin Film (OTF)
DietarySupplement
Study subjects will receive vitamin D OTF for a maximum of 12 weeks.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks from starting vitamin d supplementation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks from starting vitamin d supplementation for reporting.

Closest Location

Cincinnati Children's Hospital Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex of any age. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.

Patient Q&A Section

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

How does oral thin film (otf) cholecalciferol (vitamin d3) work?

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Vitamin D3 tablets are a cost-effective alternative (about 1/6 that of otf cholecal) for correcting vitamin D3 deficiency and this approach should be part of routine practice.

Unverified Answer

What is vitamin d deficiency?

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Vitamin D deficiency is a common health phenomenon, although in modern times it is usually attributed to lack of sun exposure and insufficient amounts of vitamin D-containing foods. It is a chronic disorder that may lead to osteomalacia as well as complications of chronic disease.

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What are the signs of vitamin d deficiency?

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Deficiency of vitamin D is prevalent in rural New Zealand; however, it remains an unrecognised issue. A minority of patients had elevated parathyroid hormone levels. For most patients with vitamin D deficiency, the cause was not identified. Most had an associated musculoskeletal condition. Vitamin D receptor (VDR) polymorphisms and low serum vitamin D were identified as predictors of mild vitamin D deficiency, highlighting the need for better recognition and evaluation of vitamin D deficiency.

Unverified Answer

What are common treatments for vitamin d deficiency?

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Vitamin D deficiency remains very common despite being diagnosed frequently by clinicians and being treated by most physicians who see patients afflicted with a range of disorders. In many cases, vitamin D deficiency is recognized by patients who do not yet seek medical treatment and is instead treated via self-treatment.

Unverified Answer

What causes vitamin d deficiency?

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VDD is a common condition with a high prevalence in the community. A low 25-OH vitamin D level is associated with various factors, including low 25-OH vitamin D levels, low bone mineral density, low protein intake, and smoking. In addition, vitamin D deficiency increases the risk of metabolic syndrome and type II diabetes mellitus in patients. Dietary modification should be considered to improve vitamin D levels.

Unverified Answer

Can vitamin d deficiency be cured?

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Vitamin D deficiency can be corrected and prevented by adequate exposure to sunlight, sufficient dietary vitamin D intake and supplementation; deficiency in serum 25(OH)D concentrations is a sign of deficient intakes of vitamin D from food sources. On this basis of proven efficacy, adequate intake of vitamin D, especially with a daily intake of at least 1000 IU, is recommended. However, it is not yet possible to conclude that serum 25(OH)D concentrations are truly cured, and serum concentrations still often are deficient in patients treated with vitamin D and who remain vitamin D deficient even in sunny seasons.

Unverified Answer

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

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About 3.5 million people of all ages have vitamin D deficiency or excess. Approximately 1 million adults in the United States are vitamin D deficient, many are of older age, obese, and use more sunlight for their sun-exposure. Nearly half of U.S. adults have insufficient blood 25-hydroxyvitamin D levels, but only a third have levels below the minimum required amounts. Nearly all children (99%), adolescents (82%), and minority groups (89%) have vitamin D deficiency or excess. Only about half the general public is aware that vitamin D deficiency can impair bone health, but it is known that high blood levels of vitamin D are linked with a dramatic decrease in many diseases, including cancer and diabetes.

Unverified Answer

Does vitamin d deficiency run in families?

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These data confirm the finding from previous studies that VDD and lower S-25-OHD concentrations are associated with an increased risk of MS after controlling for potential confounders. However, these studies are limited by their small sample size. Further prospective or other family-based studies are needed to clarify whether VDD or S-25-OHD concentrations should be used to guide vitamin D intervention trials.

Unverified Answer

Does oral thin film (otf) cholecalciferol (vitamin d3) improve quality of life for those with vitamin d deficiency?

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Otf vitamin d3 seems to be well tolerated in the long term. Olfactory function and smell perception were improved for participants. The improved QOL reported by participants may be due to improved well-being or a placebo effect.

Unverified Answer

How serious can vitamin d deficiency be?

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Vitamin D deficiency is a common problem among children across England. Vitamin D deficiency is not a harmless condition and has significant consequences for health. In light of recent evidence in older adults, we should be aware of the problem. Vitamin D deficiency is more common in young children and elderly women. It is not only a cosmetic problem as most are unaware of how serious or debilitating the condition can become with long-term vitamin D deficiencies. We need to educate people about the seriousness of vitamin D deficiency. We need to encourage children and elders to obtain enough vitamin D throughout their lives. We need to reassure people suffering from vitamin D deficiency that regular sun exposure and eating enough seafood and eggs will naturally maintain sufficient levels of vitamin D for health.

Unverified Answer

What are the common side effects of oral thin film (otf) cholecalciferol (vitamin d3)?

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The common short term side effects of otf cholecalciferol (vitamin d3) supplementation may be more tolerable for patients if the supplement and prescription can be easily accessed via a dispensing machine.

Unverified Answer

Have there been other clinical trials involving oral thin film (otf) cholecalciferol (vitamin d3)?

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Oral cholecalciferol for the purposes of improving bone density and muscle strength is widely accepted, and there have been several open studies. OTF cholecalciferol is a relatively new treatment and so there could be some risks and adverse effects associated with its usage. It is recommended that you seek the assistance of your healthcare professional before starting new or changing supplements.

Unverified Answer
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