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

NCT01277913 | Completed Phase 4

• 1 other identifier: 1/2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 1

Keywords

diabetes; vitamin D; bone density; children

Outcome Measures

Primary Outcomes (4)

• Percentage of patients with normal bone mineral density (z-score>-1)at lumbar spine(L2-L4)and total body after 12mo of supplementation

  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

  12 month

• Percentage of patients with adequate 25 hydroxyvitamin level ( >50 ng/ml)

  every 3 month in spring summer autumn and winter each patient will have blood testing for the serum level of 25hydroxyvitamin D.

  12 month

• Mean bone mineral density z-score (L2-L4, total body) after 12 mo of supplementation

  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

  12 month

• Mean isometric hand grip force

  assessed at 6 and 12 mo of supplementation

  12 month

Secondary Outcomes (5)

• Mean bone mineral density change after 12 mo of supplementation

  12 mo

• Mean serum level of TNF-alfa, osteoprotegerin, IL-6

  12 mo

• Mean HBA1C level

  12 mo

• % patients with HbA1C < 7,5 mg%

  12 mo

• % 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

  12 mo

Study Arms (2)

Vitamin D 1000 IU

EXPERIMENTAL

vitamin D will be given 1000 IU for 12 months

Drug: Vitamin D3

Vitamin D 500IU

ACTIVE COMPARATOR

vitamin D 500 IU will be given for 12 months once daily

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

1000 IU once daily for 12 months

Also known as: Vigantoletten 1000

Vitamin D 1000 IU

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatrics

Warsaw, 01-410, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pimiary investigator

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2011-01

Locations

PL (1)