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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03228862

Enrollment

360

Registered

2017-07-25

Start date

2017-05-01

Completion date

2018-02-01

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D2 Supplementation in Vitamin D Insufficiency

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.

Interventions

DRUGErgocalciferol

Ergocalciferol 40000, 60000 and 80000 once weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026