Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation

NCT01170507 | Withdrawn Phase 1

• 1 other identifier: RAC 2101042
• Study Type: interventional
• Target: N/A
• 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. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known. The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.

Conditions

Vitamin D Deficiency

Keywords

vitamin D3, 25 OH vitamin D3 level

Outcome Measures

Primary Outcomes (1)

• Slope of 25 OH vitamin D3 level vs vitamin D3 dose

  The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.

  5 months

Secondary Outcomes (4)

• slope of vitamin D3 level vs vitamin D3 dose

  5 months

• incidence of hypercalcemia

  8 months

• incidence of hypercalciuria

  8 months

• slope of decline of 25 OH vitamin D3 level vs time

  3 months

Study Arms (4)

vitamin D3 1000 IU

ACTIVE COMPARATOR

Drug: vitamin D3 1000 IU orally daily for 5 months

Vitamin D3 3000 IU

ACTIVE COMPARATOR

Drug: vitamin D3 3000 IU orally daily for 5 months

Vitamin D3 5000 IU

ACTIVE COMPARATOR

Drug: vitamin D3 5000 IU orally daily for 5 months

Placebo

PLACEBO COMPARATOR

Drug: Placebo orally daily for 5 months

Interventions

vitamin D3 1000 IU orally daily for 5 months DRUG

vitamin D3 1000 IU

vitamin D3 3000 IU orally daily for 5 months DRUG

Vitamin D3 3000 IU

vitamin D3 5000 IU orally daily for 5 months DRUG

Vitamin D3 5000 IU

Placebo orally daily for 5 months DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

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: phase 1
• 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: December 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

SA (1)