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

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03228862
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9.1
• Patients Per Site Per Month: 39.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D2 Supplementation in Vitamin D Insufficiency	Drug: Ergocalciferol	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2017
• Anticipated Primary Completion Date: Feb 1, 2018
• Anticipated Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D40000 Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly	Drug: Ergocalciferol; Ergocalciferol 40000, 60000 and 80000 once weekly
Experimental: D60000 Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly	Drug: Ergocalciferol; Ergocalciferol 40000, 60000 and 80000 once weekly
Experimental: D80000 Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly	Drug: Ergocalciferol; Ergocalciferol 40000, 60000 and 80000 once weekly

Outcome Measures

Primary Outcome Measures

1. serum 25OHD phase 1 [12 weeks]

   serum 25OHD concentration after initial vitamin D2 supplemetaiton

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital	Bangkok		Thailand	13310

Sponsors and Collaborators

• Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lalita Wattanachanya, MD, Assist Prof., Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT03228862
• Other Study ID Numbers: 088/60
• First Posted: Jul 25, 2017
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency; Ergocalciferols; Vitamin D

Study Results

No Results Posted as of Jul 26, 2017