Vitamin D Oral Replacement in Asthma (VDORA1)

IDeA States Pediatric Clinical Trials Network

Status: Completed

Conditions: Asthma; Vitamin D Deficiency; Pediatric Obesity

Treatments: Dietary Supplement: Vitamin D3 oral regimen

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT03686150

U24OD024957 (U.S. NIH Grant/Contract)

101

Details and patient eligibility

About

The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.

Full description

This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.

In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.

Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.

Enrollment: 112 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index greater than or equal to 85% for age and sex
• Physician-diagnosed asthma
• Ongoing relationship with asthma provider responsible for asthma care
• Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
• Ability to swallow pills similar in size to the vitamin D preparation to be used
• Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
• Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
• Child and parent, legal guardian, or caregiver must speak English or Spanish

Exclusion criteria

• Known diseases of calcium metabolism or the parathyroid
• History of renal insufficiency or kidney stones
• Known liver failure or history of abnormal liver function tests
• History of Williams syndrome, sarcoidosis, or granulomatous disease
• Active tuberculosis
• Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
• Clinical evidence of rickets
• Taking supplemental vitamin D greater than equal to 1000 IU per day

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 6 patient groups

Part 1, Cohort 1 Vitamin D3 oral regimen

Experimental group

Description:

Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose

Treatment:

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 2 Vitamin D3 oral regimen

Experimental group

Description:

Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose

Treatment:

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 3 Vitamin D3 oral regimen

Experimental group

Description:

Vitamin D: 6000 IU daily dose

Treatment:

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 4 Vitamin D3 oral regimen

Active Comparator group

Description:

Vitamin D: 600 IU daily dose

Treatment:

Dietary Supplement: Vitamin D3 oral regimen

Part 2, Cohort A Vitamin D3 oral regimen

Experimental group

Description:

Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD

Treatment:

Dietary Supplement: Vitamin D3 oral regimen

Part 2, Cohort B Vitamin D oral regimen

Active Comparator group

Description:

Vitamin D: 600 IU daily dose

Treatment:

Dietary Supplement: Vitamin D3 oral regimen