NCT03035084

Brief Summary

Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level. The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 15, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

January 15, 2017

Last Update Submit

August 9, 2018

Conditions

Vitamin D Deficiency25-Hydroxyvitamin D Concentration

Outcome Measures

Primary Outcomes (2)

  • ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1

    day 28

  • ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2

    day 28

Secondary Outcomes (5)

  • ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1

    day 56

  • ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2

    day 56

  • Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level

    day 28

  • Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level

    day 28

  • Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group

    day 28

Study Arms (4)

Group-2-D3

EXPERIMENTAL

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3

Drug: Vitamin D3Drug: Vitamin D2

Group-2-Placebo

PLACEBO COMPARATOR

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.

Drug: Vitamin D2Drug: Placebo oral capsule

Group-1-D2

EXPERIMENTAL

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.

Drug: Vitamin D2

Group-1-Placebo

PLACEBO COMPARATOR

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.

Drug: Placebo oral capsule

Interventions

Vitamin D3DRUG

Single oral dose of 50,000 IU of vitamin D3

Also known as: cholecalciferol
Group-2-D3
Vitamin D2DRUG

Single oral dose of 50,000 IU of vitamin D2

Also known as: Ergocalciferol
Group-1-D2Group-2-D3Group-2-Placebo
Placebo oral capsuleDRUG

Placebo oral capsule

Group-1-PlaceboGroup-2-Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-pregnant adults (age ≥18 years)
  • healthy
  • total 25(OH)D level between 20 to 65 nmol/L.
  • living in Riyadh area

You may not qualify if:

  • consumption of more than one serving of milk daily
  • taking vitamin D supplements
  • habitual weekly sun exposure of 10 hours or more
  • history of granulomatous, liver, or kidney disease
  • taking anticonvulsants, barbiturates, or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, Central, 11211, Saudi Arabia

Location

Related Publications (1)

  • Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.

    PMID: 30658603DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolErgocalciferols

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Muhammad M Hammami, MD, PhD

    King Faisal Specialist Hospital & Research Center (Riydah)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 27, 2017

Study Start

February 15, 2017

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

SA(1)