NCT03228862

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

July 21, 2017

Last Update Submit

July 24, 2017

Conditions

Vitamin D2 Supplementation in Vitamin D Insufficiency

Outcome Measures

Primary Outcomes (1)

  • serum 25OHD phase 1

    serum 25OHD concentration after initial vitamin D2 supplemetaiton

    12 weeks

Study Arms (3)

D40000

EXPERIMENTAL

Patients are randomly assigned to receive Ergocalciferol 40000 IU once weekly

Drug: Ergocalciferol

D60000

EXPERIMENTAL

Patients are randomly assigned to receive Ergocalciferol 60000 IU once weekly

Drug: Ergocalciferol

D80000

EXPERIMENTAL

Patients are randomly assigned to receive Ergocalciferol 80000 IU once weekly

Drug: Ergocalciferol

Interventions

ErgocalciferolDRUG

Ergocalciferol 40000, 60000 and 80000 once weekly

D40000D60000D80000

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult age ≥ 15 years
  • BMI 18 - 35 kg/m2
  • Serum 25(OH)D \< 30ng/ml

You may not qualify if:

  • Hypercalcemia, nephrolithiasis, or fractures
  • Hepatic disease
  • Kidney disease
  • Granulomatous disease
  • Currently supplemented with vitamin D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn Univerity and King Chulalongkorn Memorial Hospital

Bangkok, 13310, Thailand

Location

MeSH Terms

Interventions

Ergocalciferols

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

July 21, 2017

First Posted

July 25, 2017

Study Start

May 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

TH(1)