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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D2 Supplementation in Vitamin D Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D40000

Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly

Group Type EXPERIMENTAL

Ergocalciferol

Intervention Type DRUG

Ergocalciferol 40000, 60000 and 80000 once weekly

D60000

Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly

Group Type EXPERIMENTAL

Ergocalciferol

Intervention Type DRUG

Ergocalciferol 40000, 60000 and 80000 once weekly

D80000

Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly

Group Type EXPERIMENTAL

Ergocalciferol

Intervention Type DRUG

Ergocalciferol 40000, 60000 and 80000 once weekly

Interventions

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Ergocalciferol

Ergocalciferol 40000, 60000 and 80000 once weekly

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes