Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.

The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: ergocalciferol 2000 IU orally, daily; Drug: cholecalciferol 2000 IU orally daily; Drug: ergocal1000 IU & cholecal 1000 IU orally daily; Drug: ergocalciferol 25000 IU oraly every 2 weeks; Drug: Cholecalciferol 25000 IU orally every 2 weeks; Drug: ergocalciferol 50000 IU orally every 4 weeks; Drug: Cholecalciferol 50000 orally every 4 weeks; Drug: placebo orally everyday

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
• 25 OH vitamin D level between 20 to 50 nmol/L.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: D2 2000 IU daily	Drug: ergocalciferol 2000 IU orally, daily; ergocalciferol 2000 IU orally, daily; Other Names: ergocalciferol
ACTIVE_COMPARATOR: D3 2000 IU daily	Drug: cholecalciferol 2000 IU orally daily; cholecalciferol 2000 IU orally everyday; Other Names: cholecalciferol
ACTIVE_COMPARATOR: D2 1000 IU + D3 1000 IU daily	Drug: ergocal1000 IU & cholecal 1000 IU orally daily; ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day; Other Names: ergocalciferol and cholecalciferol
ACTIVE_COMPARATOR: D2 25000 IU Q2wk	Drug: ergocalciferol 25000 IU oraly every 2 weeks; ergocalciferol 25000 IU oraly every 2 weeks; Other Names: ergocalciferol
ACTIVE_COMPARATOR: D3 25000 IU Q2wk	Drug: Cholecalciferol 25000 IU orally every 2 weeks; Cholecalciferol 25000 IU orally every 2 weeks; Other Names: Cholecalciferol
ACTIVE_COMPARATOR: D2 50000 IU Q4wk	Drug: ergocalciferol 50000 IU orally every 4 weeks; ergocalciferol 50000 IU orally every 4 weeks; Other Names: ergocalciferol
ACTIVE_COMPARATOR: D3 50000 IU Q4wk	Drug: Cholecalciferol 50000 orally every 4 weeks; Cholecalciferol 50000 orally every 4 weeks; Other Names: Cholecalciferol
PLACEBO_COMPARATOR: placebo daily	Drug: placebo orally everyday; placebo orally everyday; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area under the curve of 25 OH vitamin D level	area under the curve of total 25 OH vitamin D level from day 1 to 140	140 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of 25 OH vitamin D	Cmax of total 25 OH vitamin D over the treatment period of 140 days	140 days
Tmax of 25 OH vitamin D level	Tmax of total 25 OH vitamin D over the treatment period of 140 days	140 days
area under the curve of vitamin D level	area under the curve of total vitamin D level over 140 days	140 days
incidence of hypercalcemia		140 days
incidence of hypercalciuria		140 days

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center

Publications and helpful links

General Publications

• Hammami MM, Yusuf A. Differential effects of vitamin D2 and D3 supplements on 25-hydroxyvitamin D level are dose, sex, and time dependent: a randomized controlled trial. BMC Endocr Disord. 2017 Feb 24;17(1):12. doi: 10.1186/s12902-017-0163-9.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: July 25, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (ESTIMATE): July 27, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: RAC 2101041