Optimal Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Adults

Vitamin D2 Supplementation in Vitamin D Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03228862
• Other study ID #: 088/60
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 21, 2017
• Last updated: July 24, 2017
• Start date: May 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 360
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Rickets
• Vitamin D Deficiency
• Vitamin D2 Supplementation in Vitamin D Insufficiency

Intervention

Drug:
• Ergocalciferol
Ergocalciferol 40000, 60000 and 80000 once weekly

Locations

Country	Name	City	State
Thailand	Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25OHD phase 1	serum 25OHD concentration after initial vitamin D2 supplemetaiton	12 weeks