- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00968734
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal (VITDAB_08606)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI.
In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clínicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Residents of the hospital clinics of Porto Alegre
Exclusion Criteria:
- Don't drink milk
- Obesity
- Malnutrition
- Liver disease
- Kidney disease or diabetes
- Use of dietary supplements containing calcium and vitamin D
- Medications
- Anticonvulsants
- Barbiturates, or steroids.
- Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low fat meal
|
50.000UI single oral dose
|
EXPERIMENTAL: Hight fat meal
|
50.000UI single oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Level of Vitamin D3
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fabiana Viegas Raimundo, graduation, Federal University of Rio Grande do Sul
- Study Director: Tania Weber Furlanetto, PhD, Federal University of Rio Grande do Sul
- Principal Investigator: Gustavo Faulhaber, Master, Federal University of Rio Grande do Sul
- Principal Investigator: Rosana Scalco, Master, Hospital de Clínicas de Porto Alegre
- Principal Investigator: Leonardo Marques, Graduation, Hospital de Clínicas de Porto Alegre
- Principal Investigator: Paula Menegatti, Graduation, Hospital de Clínicas de Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIPE, CAPES
- GPPG_080606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deficiency, Vitamin D
-
University Hospital, Clermont-FerrandTerminated
-
Rajavithi HospitalQueen Sirikit National Institute of Child HealthCompleted
-
Universidade de Passo FundoUnknownDeficiency, Vitamin DBrazil
-
Nutrition Institute, SloveniaEuropean Regional Development Fund; Vizera d.o.o.; Frutarom Etol d.o.o.CompletedVitamin B 12 Deficiency | Vitamin d Deficiency | Protein DeficiencySlovenia
-
Wageningen UniversityDSM Nutritional Products, Inc.; Top Institute Food and NutritionCompletedElderly, Frail | Deficiency, Vitamin DNetherlands
-
University of PaviaIstituti Clinici Scientifici Maugeri SpAUnknownVitamin D Deficiency | Vitamin D3 Deficiency | Vitamin DItaly
-
Okan UniversityArçelik A.Ş.Completed
-
Brigham and Women's HospitalCompletedVitamin d Deficiency
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNot yet recruitingVitamin d DeficiencyChina
-
Bispebjerg HospitalCompletedObesity | Deficiency, Vitamin D
Clinical Trials on colecalciferol
-
University Medical Center GroningenNetherlands Foundation for Cardiovascular ExcellenceCompleted
-
Faculty Hospital Kralovske VinohradyBrno University Hospital; Nemocnice T.Bati, ZlinUnknown
-
University Hospital, SaarlandCompletedHyperparathyroidism, Secondary | RENAL INSUFFICIENCY, CHRONICGermany
-
Germans Trias i Pujol HospitalFundació Institut Germans Trias i Pujol; Spanish Clinical Research Network... and other collaboratorsCompletedUrothelial CarcinomaSpain
-
Medical University of GrazAustrian Science Fund (FWF)CompletedHealthy | Polycystic Ovary Syndrome | Vitamin D DeficiencyAustria
-
National Institute of Allergy and Infectious Diseases...Department of Health and Human Services; HIV Vaccine Trials Network; Inovio Pharmaceuticals and other collaboratorsActive, not recruiting
-
Imperial College LondonWithdrawnCrohn's DiseaseUnited Kingdom
-
Radboud University Medical CenterUnknownHIV Infections | Vitamin D DeficiencyNetherlands
-
Amsterdam UMC, location VUmcRadboud University Medical Center; Leiden University Medical CenterCompletedChronic Obstructive Pulmonary DiseaseNetherlands
-
University of TurkuUnknownColecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Multiple SclerosisFinland