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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency	Drug: vitamin D3 1000 IU orally daily for 5 months; Drug: vitamin D3 3000 IU orally daily for 5 months; Drug: vitamin D3 5000 IU orally daily for 5 months; Drug: Placebo orally daily for 5 months	Phase 1; Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
Study Start Date :	December 2011
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: vitamin D3 1000 IU	Drug: vitamin D3 1000 IU orally daily for 5 months
Active Comparator: Vitamin D3 3000 IU	Drug: vitamin D3 3000 IU orally daily for 5 months
Active Comparator: Vitamin D3 5000 IU	Drug: vitamin D3 5000 IU orally daily for 5 months
Placebo Comparator: Placebo	Drug: Placebo orally daily for 5 months

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Slope of 25 OH vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]
   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.

Secondary Outcome Measures :

1. slope of vitamin D3 level vs vitamin D3 dose [ Time Frame: 5 months ]
   slope of vitamin D3 level vs vitamin D3 dose over 5 months
2. incidence of hypercalcemia [ Time Frame: 8 months ]
   incidence of hypercalcemia over 8 months
3. incidence of hypercalciuria [ Time Frame: 8 months ]
   incidence of hypercalciuria over 8 months
4. slope of decline of 25 OH vitamin D3 level vs time [ Time Frame: 3 months ]
   slope of decline of 25 OH vitamin D3 level vs time over 3 months

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• 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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

Investigators

Principal Investigator:	Muhammad M Hammami, MD, PhD	King Faisal Specialist Hospital & Research Center

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:	NCT01170507 History of Changes
Other Study ID Numbers:	RAC 2101042
First Posted:	July 27, 2010
Last Update Posted:	March 7, 2018
Last Verified:	March 2018

Keywords provided by Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center:

vitamin D3, 25 OH vitamin D3 level

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamins; Vitamin D	Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents