Effect of vitamin D deficiency correction on serum Fibroblast growth factor 23 level in vitamin D deficient patients and comparision with vitamin D deficient patients
Goal: investigating the effect of vitamin D supplement on serum Fibroblast growth factor 23 level in vitamin D deficient patients.
Inclusion and exclusion criteria:
The study was performed on vitamin D deficient patients. Vitamin D deficiency is defined as serum vitamin D level below 20 ng/ml.vitamin D deficient patients were treated with 50000 unit vitamin D per week for 12 weeks. level of Calcium; Phosphorous;Alkaline phosaphatase; PTH;FGF23;25-hydroxy vitamin D and 1,25-dihydroxy vitamin D after therapy were assessed.
Society of the study:
Vitamin D deficient patients in both sexes and in range 15-90 years old were included in this study.
Volume of the Sample:
Study was enrolled 119 vitamin D deficient patients who were divided in to case and control groups.
Intervention, duration and result:
The patients were enrolled through a simple random sampling and were also blindly divided in two groups.
"First group, patients were given 50,000 IU of vitamin D3 (Colecalciferol) once a week for 12 weeks, manufactured by Roche pharmaceutical, Tehran, Iran" and "the controls were given olive oil capsules as placebo".
After 12 weeks of therapy, second samples were taken from the patients. Only one physician knew each patients codes that had received vitamin D, and was not in contact with patients. Both the physician and the patients were blind to what each patient had received. After termination of the study, all the patients in the control group received proper dose of vitamin D3.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138707171312N1
Registration date:2017-05-16, 1396/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Mohammad Hossein Dabbaghmanesh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 8728
Email address
dabbaghm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology and Metabolic Department of "Shiraz University of Medical ُُSciences"
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-06-07, 1395/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D deficiency correction on serum Fibroblast growth factor 23 level in vitamin D deficient patients and comparision with vitamin D deficient patients
Public title
Effect of vitamin D deficiency correction on serum Fibroblast growth factor 23 level
Purpose
Treatment
Inclusion/Exclusion criteria
Vitamin D deficient patients (serum vitamin D level under 20 ng/ml) in both sexes and in range 15-90 years old were included in this study. patients who had underlying diseases such as osteomalacia, renal failure,hyperparathyroidism; hypoparathyroidism; osteoporesis; hereditary bone disease such as autosomal dominant hypophosphatemic rickets; autosomal recessive hypophosphatemic rickets, vitamin D resistant rickets; vitamin D dependent rickets; X- linked hypophosphatemia autosomal recessive hypophosphatemia and fibrous dysplasia; recent consumption of calcium supplement; concurrent use of drugs that interfere with vitamin D such as iron supplement; Alluminum and Magnesium admixture such as anti acid drugs; proton pump inhibitors (PPI) like Omeprazole or pantoprazole; bile acid binding resins like cholestyramine; cardiac glycosides such as Digoxin; Danazole; Multi vitamin and minerals; Sucralfate;Orlistat;Thiazide diuretic; alcohol consumption; consumption of other analogs of vitamin D; Herbal drugs; use of Olive; pregnant and lactating women were exclude from the study.
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
none
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street central department of Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193711351
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.SUMS.REC.1395.17
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
FGF23
Timepoint
Basal and 3 month after
Method of measurement
blood sample
Secondary outcomes
1
Description
calcium
Timepoint
Basal and 3 month after
Method of measurement
blood sample
Intervention groups
1
Description
In case group patients with vitamin D deficiency were treated with 50000 unit vitamin D on fridays for 3 months and at the end of 3 months level of Calcium , Phosphorous ,Fibroblast growth factor 23, Parathormon , 1,25- hydroxyl vitamin D ,25-hydroxy vitamin D , and Alkaline phoaphatase, were checked .
Category
Treatment - Drugs
2
Description
In control group patients were treated with placebo( olive oil capsule) on fridays for 3 months and at the end of 3 months, level of Calcium , Phosphorous, fibroblast growth factor 23, parathormon , 1,25- hydroxy vitamin D, 25-hydroxy vitamin D , and Alkaline phoaphatase were checked .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Department of Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein Ranjbar Omrani
Street address
Endocrinology & Metabolism Department of Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hashemi Seyed Basir MD
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Forugh Saki
Position
Assistant Professor Shiraz University of Medical Science
Other areas of specialty/work
Street address
Endocrinology & Metabolism Department of Shiraz University of Medical Science
City
Shiraz
Postal code
7193711351
Phone
+98 917 712 7122
Fax
Email
Forughs@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology & Metabolism Department of Shiraz University of Medical Sciences
Full name of responsible person
Gholamhossein Ranjbar Omrani
Position
Professor
Other areas of specialty/work
Street address
Endocrinology & Metabolism Department of Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193711351
Phone
+98 71 3628 1569
Fax
Email
hormone@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Namazi hospital Shiraz University of Medical Sciences
Full name of responsible person
Toktam Kamelian
Position
Fellow of adult Endocrinolgy & Metabilic disease
Other areas of specialty/work
Street address
Medical college of Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193711351
Phone
+98 71 3628 1569
Fax
Email
kamelian.t92@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)