Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Gastrointestinal, Pulmonary |
| Therapuetic Areas: | Gastroenterology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 10/18/2018 |
| Start Date: | November 2016 |
| End Date: | December 2020 |
Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than
or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to
participate in this study. Upon consent, they will be given oral cholecalciferol
supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed
by measuring a serum calcium level within 1 week of supplementation. Efficacy will be
assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be
assessed with the previous two measures as well as a brief questionnaire administered via
telephone within 1 week of supplementation.
or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to
participate in this study. Upon consent, they will be given oral cholecalciferol
supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed
by measuring a serum calcium level within 1 week of supplementation. Efficacy will be
assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be
assessed with the previous two measures as well as a brief questionnaire administered via
telephone within 1 week of supplementation.
Children and adults with Cystic Fibrosis (CF) are at risk of developing a vitamin D
deficiency or insufficiency, defined as a 2,25-hydroxyvitamin D (25OHD) serum blood level <30
ng/dL. Greater than 85% of people with CF have pancreatic insufficiency, which contributes to
poor absorption of fat soluble vitamins in addition to dietary fat. A 25OHD level greater
than 30 ng/dL has been described as providing potential improvements to markers of
inflammation in adults with CF and is known to improve bone mineral density and prevent bone
fractures in all populations, including CF. This study will assess the safety of a one-time
high dose of cholecalciferol or vitamin D3 along with the efficacy and feasibility.
Children between the ages of 3 years and 18 years (inclusive), with a 25OHD level <30 ng/dL
will be provided with a vitamin D3 supplement of 250,000 international units (IU) observed in
our CF clinic. We hypothesize that this one-time, oral, high dose of vitamin D3 will safely
and effectively raise the 25OHD level to above 30 ng/dL.
Safety will be monitored with serum calcium levels 1 week following the dosage, since 25OHD
has a half-life of 2-3 weeks and this serum calcium level measurement time-point would be in
or near the middle of this range. Feasibility will be measured using a 5-question phone
survey 1 week following the dosage (see appendix A - attached). Efficacy will be measured by
the 25OHD level itself; if 25OHD levels are found to be between 30-100 ng/dL over the course
of the study, the dose will have demonstrated effective in achieving the study's goal.
The purpose of this study is to show that 25OHD levels can be safely corrected with a
one-time dose of vitamin D3 that can be safely and feasibly provided in the outpatient
setting to children with CF.
deficiency or insufficiency, defined as a 2,25-hydroxyvitamin D (25OHD) serum blood level <30
ng/dL. Greater than 85% of people with CF have pancreatic insufficiency, which contributes to
poor absorption of fat soluble vitamins in addition to dietary fat. A 25OHD level greater
than 30 ng/dL has been described as providing potential improvements to markers of
inflammation in adults with CF and is known to improve bone mineral density and prevent bone
fractures in all populations, including CF. This study will assess the safety of a one-time
high dose of cholecalciferol or vitamin D3 along with the efficacy and feasibility.
Children between the ages of 3 years and 18 years (inclusive), with a 25OHD level <30 ng/dL
will be provided with a vitamin D3 supplement of 250,000 international units (IU) observed in
our CF clinic. We hypothesize that this one-time, oral, high dose of vitamin D3 will safely
and effectively raise the 25OHD level to above 30 ng/dL.
Safety will be monitored with serum calcium levels 1 week following the dosage, since 25OHD
has a half-life of 2-3 weeks and this serum calcium level measurement time-point would be in
or near the middle of this range. Feasibility will be measured using a 5-question phone
survey 1 week following the dosage (see appendix A - attached). Efficacy will be measured by
the 25OHD level itself; if 25OHD levels are found to be between 30-100 ng/dL over the course
of the study, the dose will have demonstrated effective in achieving the study's goal.
The purpose of this study is to show that 25OHD levels can be safely corrected with a
one-time dose of vitamin D3 that can be safely and feasibly provided in the outpatient
setting to children with CF.
Inclusion Criteria:
- Children with Cystic Fibrosis >36 months of age
- Serum/blood 25OHD level < 30 ng/dL
- Ability to provide valid informed consent to be a part of the study
Exclusion Criteria:
- Any history of kidney disease, kidney stones or on dialysis
- Any history of hypercalcemia
- Any history of hypercalciuria
- Pregnancy at time of enrollment
- Any history of parathyroid disorders
- Inability to swallow pills by mouth
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