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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
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D2 Supplementation in Vitamin D Insufficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult age ≥ 15 years
  2. BMI 18 - 35 kg/m2
  3. Serum 25(OH)D < 30ng/ml

Exclusion Criteria:

  1. Hypercalcemia, nephrolithiasis, or fractures
  2. Hepatic disease
  3. Kidney disease
  4. Granulomatous disease
  5. 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

First Posted
July 21, 2017
Last Updated
July 24, 2017
Sponsor
Chulalongkorn University
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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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