The Effect of Supplementation With Two Different Doses of Vitamin D on Bone Mineral Density, Vitamin D Levels and Hand Grip Strength in Children With Diabetes Mellitus Type 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piotr Dziechciarz, MD, Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01277913
First received: January 14, 2011
Last updated: November 3, 2013
Last verified: January 2011
  Purpose

The aim of the study is to assess the effect of 12 month supplementation with two different doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels and hand grip strength in preadolescents with diabetes mellitus type 1.

100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3 months, without history of diabetic ketoacidosis during previous month, without other chronic disease which may affect calcium-phosphorus metabolism will be randomized in a double blind controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months, in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c will be measured. At the entry and at the end of the study patients will have total body and lumbar spine bone mineral density assessment. Every six months hand grip strength will be measured. Additionally at the beginning and after 12 mo of supplementation and at the beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.


Condition Intervention Phase
Diabetes Mellitus Type 1
Drug: Vitamin D3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Supplementation With Two Different Doses of Vitamin D (500 IU vs 1000IU)on Bone Mineral Density, Serum 25 Hydroxyvitamin D and Hand Grip Strength in Children With Diabetes Mellitus Type 1 - a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Percentage of patients with normal bone mineral density (z-score>-1)at lumbar spine(L2-L4)and total body after 12mo of supplementation [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D

  • Percentage of patients with adequate 25 hydroxyvitamin level ( >50 ng/ml) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    every 3 month in spring summer autumn and winter each patient will have blood testing for the serum level of 25hydroxyvitamin D.

  • Mean bone mineral density z-score (L2-L4, total body) after 12 mo of supplementation [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Bone mineral density will be assessed with DEXA (dual energy X ray absorptiometry)method at the beginning of the study and after 12 month of supplementation with vitamin D

  • Mean isometric hand grip force [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    assessed at 6 and 12 mo of supplementation


Secondary Outcome Measures:
  • Mean bone mineral density change after 12 mo of supplementation [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Mean serum level of TNF-alfa, osteoprotegerin, IL-6 [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • Mean HBA1C level [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
    HBA1c level will be assessed at summer,spring,autumn and winter.

  • % patients with HbA1C < 7,5 mg% [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
  • % patients with vitamin D hypervitaminosis (>200 ng/ml (500 nmol/L) and or hypercalcemia (>2.7 mmol/l) assessed at summer,spring, autumn, and winter [ Time Frame: 12 mo ] [ Designated as safety issue: Yes ]
    it will be assessed at summer,spring, autumn, and winter


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D 1000 IU
vitamin D will be given 1000 IU for 12 months
Drug: Vitamin D3
1000 IU once daily for 12 months
Other Name: Vigantoletten 1000
Active Comparator: Vitamin D 500IU
vitamin D 500 IU will be given for 12 months once daily
Drug: Vitamin D3
500 IU once daily for 12 months
Other Name: Vigantoletten 500

Detailed Description:

Evidence indicates that majority (75-90%) of children with diabetes have lower serum concentrations of vitamin D, which may negatively impacts bone health and can be associated with reduction of muscular strength. There is still unknown what is the optimal dose of vitamin D in these patients for adequate supply of vitamin D throughout the year to assure optimal peak bone mass and muscle strengthThe aim of the study is to assess the effect of 12 month supplementation with two different doses of vitamin D ( 500 vs 1000) on bone mineral density, serum 25 hydroxyvitamin D levels and hand grip strength in preadolescents with diabetes mellitus type 1.

100 children in the of age 8 -11 with diabetes mellitus type 1 lasting for more than 3 months, without history of diabetic ketoacidosis during previous month, without other chronic disease which may affect calcium-phosphorus metabolism will be randomized in a double blind controlled trial to supplement them with either 500 IU or 1000 IU vitamin D. Every 3 months, in spring summer,autumn and winter serum level of calcium,25-hydroxyvitamin D level and HbA1c will be measured. At the entry and at the end of the study patients will have total body and lumbar spine bone mineral density assessment. Every six months hand grip strength will be measured. Additionally at the beginning and after 12 mo of supplementation and at the beginning serum levels of TNF-alfa, osteoprotegerin and IL-6 will be assessed.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 8-11 years
  • Diabetes type I lasting for more than 3 months
  • informed consent given

Exclusion Criteria:

  • Adolescence (Tanner stage ≥ 2 for each of the variable)
  • Chronic diseases affecting calcium-phosphorus metabolism (hepatic disease, chronic kidney disease, primary phosphate deficiencies, end organ resistance to 1,25OH S genetically)
  • Hypervitaminosis D > 200 ng/ml (500 nmol/L)
  • Diabetic ketoacidosis during last month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277913

Locations
Poland
Department of Pediatrics
Warsaw, Poland, 01-410
Sponsors and Collaborators
Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Piotr Dziechciarz, MD, pimiary investigator, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01277913     History of Changes
Other Study ID Numbers: 1/2011
Study First Received: January 14, 2011
Last Updated: November 3, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
diabetes
vitamin D
bone density
children

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014