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

NCT01170494 | Completed

• 1 other identifier: RAC 2101041
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin D Deficiency

Keywords

vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cmax of 25 OH vitamin D

  140 days

• Tmax of 25 OH vitamin D level

  140 days

• area under the curve of vitamin D level

  140 days

• incidence of hypercalcemia

  140 days

• incidence of hypercalciuria

  140 days

Study Arms (8)

D2 2000 IU daily

ACTIVE COMPARATOR

Drug: ergocalciferol 2000 IU orally, daily

D3 2000 IU daily

ACTIVE COMPARATOR

Drug: cholecalciferol 2000 IU orally daily

D2 1000 IU + D3 1000 IU daily

ACTIVE COMPARATOR

Drug: ergocal1000 IU & cholecal 1000 IU orally daily

D2 25000 IU Q2wk

ACTIVE COMPARATOR

Drug: ergocalciferol 25000 IU oraly every 2 weeks

D3 25000 IU Q2wk

ACTIVE COMPARATOR

Drug: Cholecalciferol 25000 IU orally every 2 weeks

D2 50000 IU Q4wk

ACTIVE COMPARATOR

Drug: ergocalciferol 50000 IU orally every 4 weeks

D3 50000 IU Q4wk

ACTIVE COMPARATOR

Drug: Cholecalciferol 50000 orally every 4 weeks

placebo daily

PLACEBO COMPARATOR

Drug: placebo orally everyday

Interventions

ergocalciferol 2000 IU orally, daily DRUG

ergocalciferol 2000 IU orally, daily

Also known as: ergocalciferol

D2 2000 IU daily

ergocalciferol 25000 IU oraly every 2 weeks DRUG

ergocalciferol 25000 IU oraly every 2 weeks

Also known as: ergocalciferol

D2 25000 IU Q2wk

ergocalciferol 50000 IU orally every 4 weeks DRUG

ergocalciferol 50000 IU orally every 4 weeks

Also known as: ergocalciferol

D2 50000 IU Q4wk

ergocal1000 IU & cholecal 1000 IU orally daily DRUG

ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day

Also known as: ergocalciferol and cholecalciferol

D2 1000 IU + D3 1000 IU daily

cholecalciferol 2000 IU orally daily DRUG

cholecalciferol 2000 IU orally everyday

Also known as: cholecalciferol

D3 2000 IU daily

Cholecalciferol 25000 IU orally every 2 weeks DRUG

Cholecalciferol 25000 IU orally every 2 weeks

Also known as: Cholecalciferol

D3 25000 IU Q2wk

Cholecalciferol 50000 orally every 4 weeks DRUG

Cholecalciferol 50000 orally every 4 weeks

Also known as: Cholecalciferol

D3 50000 IU Q4wk

placebo orally everyday DRUG

placebo orally everyday

Also known as: placebo

placebo daily

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• OH vitamin D level between 20 to 50 nmol/L.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & research Center

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 28231782 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Muhammad M Hammami, MD, PhD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Chairman, Department of Clinical Studies & Empirical Ethics

Study Record Dates

• First Submitted: July 25, 2010
• First Posted: July 27, 2010
• Study Start: February 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

SA (1)