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

Phase 4

• Conditions: Vitamin D2 Supplementation in Vitamin D Insufficiency
• Interventions: Drug: Ergocalciferol

• Registration Number: NCT03228862
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Last Update Submitted: 2017-07-24
• Study First Posted: 2017-07-25
• Last Update Posted: 2017-07-26
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D60000	Ergocalciferol	Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly
D40000	Ergocalciferol	Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly
D80000	Ergocalciferol	Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly

Primary Outcome Measures

Name	Time	Method
serum 25OHD phase 1	12 weeks	serum 25OHD concentration after initial vitamin D2 supplemetaiton

Trial Locations

Locations (1)

Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand