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

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ClinicalTrials.gov Identifier: NCT03228862
Recruitment Status : Unknown
Verified July 2017 by Lalita Wattanachanya, MD, Chulalongkorn University.
Recruitment status was:  Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Lalita Wattanachanya, MD, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : February 1, 2018


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




Primary Outcome Measures :
  1. serum 25OHD phase 1 [ Time Frame: 12 weeks ]
    serum 25OHD concentration after initial vitamin D2 supplemetaiton



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228862


Locations
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Thailand
Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 13310
Sponsors and Collaborators
Chulalongkorn University
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Responsible Party: Lalita Wattanachanya, MD, Assist Prof., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03228862    
Other Study ID Numbers: 088/60
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Ergocalciferols
Vitamin D
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents