Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults
Primary Purpose
Vitamin D2 Supplementation in Vitamin D Insufficiency
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ergocalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D2 Supplementation in Vitamin D Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Adult age ≥ 15 years
- BMI 18 - 35 kg/m2
- Serum 25(OH)D < 30ng/ml
Exclusion Criteria:
- Hypercalcemia, nephrolithiasis, or fractures
- Hepatic disease
- Kidney disease
- Granulomatous disease
- Currently supplemented with vitamin D
Sites / Locations
- Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
D40000
D60000
D80000
Arm Description
Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly
Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly
Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly
Outcomes
Primary Outcome Measures
serum 25OHD phase 1
serum 25OHD concentration after initial vitamin D2 supplemetaiton
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228862
Brief Title
Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults
Official Title
Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Anticipated)
Study Completion Date
February 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the optimal initial and maintenance doses of vitamin D2 supplementation for the treatment of vitamin D insufficiency in Thai adults, and to determine the prevalence of and risk factors for hypovitaminosis D among Thai adults.
Detailed Description
A double-blinded prospective, randomized study undertaken at outpatient clinic of King Chulalongkorn Memorial Hospital. The patients with vitamin D insufficiency were included and divided into three groups according to their initial 25OHD concentrations. Patients are randomly assigned to receive vitamin D2 40000, 60000 or 80000 IU once weekly. Serum 25(OH)D levels are measured at 12 weeks after vitamin D2 supplemetaiton. The patients with 25OHD more than 30ng/mL are enroll into the maintenance phase of the study and are randomly assigned to receive vitamin D2 20000 or 40000 IU once weekly for another 12 months. The 25OHD concentration are measure again at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D2 Supplementation in Vitamin D Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D40000
Arm Type
Experimental
Arm Description
Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly
Arm Title
D60000
Arm Type
Experimental
Arm Description
Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly
Arm Title
D80000
Arm Type
Experimental
Arm Description
Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Intervention Description
Ergocalciferol 40000, 60000 and 80000 once weekly
Primary Outcome Measure Information:
Title
serum 25OHD phase 1
Description
serum 25OHD concentration after initial vitamin D2 supplemetaiton
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult age ≥ 15 years
BMI 18 - 35 kg/m2
Serum 25(OH)D < 30ng/ml
Exclusion Criteria:
Hypercalcemia, nephrolithiasis, or fractures
Hepatic disease
Kidney disease
Granulomatous disease
Currently supplemented with vitamin D
Facility Information:
Facility Name
Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
13310
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults
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