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

July 24, 2017 updated by: Lalita Wattanachanya, MD, Chulalongkorn University

Optimal Initial and Maintenance Doses of Ergocalciferol Supplementation for Treatment of Hypovitaminosis D in Thai Adults: A Randomized, Double-blinded Dose-comparison Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 13310
        • Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum 25OHD phase 1
Time Frame: 12 weeks
serum 25OHD concentration after initial vitamin D2 supplemetaiton
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 088/60

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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