Oral Vitamin D Supplementation in Elderly Women

This study has been completed.
Sponsor:
Collaborators:
Päivikki and Sakari Sohlberg Foundation, Finland
Lilly Foundation
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00575835
First received: December 17, 2007
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments


Condition Intervention
Optimal Vitamin D Administration
Dietary Supplement: vitamin D twice daily
Dietary Supplement: Vitamin D3 oil three times in a year

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Blood 25 OH D vitamin concentrations [ Time Frame: 8 times during the year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • serum calcium, 24-hour calcium excretion in urine, creatinine clearance [ Time Frame: 8 times during the year ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: October 2007
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: vitamin D twice daily
Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
Experimental: 2 Dietary Supplement: Vitamin D3 oil three times in a year
Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year

  Eligibility

Ages Eligible for Study:   70 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females
  • 70-80 years
  • Living in the community

Exclusion Criteria:

  • Renal disease
  • Diseases that contraindicate vitamin D supplementation
  • Medications affecting bone
  • Malignancy
  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: NCT00575835

Locations
Finland
Helsinki University Central Hospital, department of medicine, division of endocrinology
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
Päivikki and Sakari Sohlberg Foundation, Finland
Lilly Foundation
  More Information

No publications provided

Responsible Party: Matti Välimäki, MD, Ph.D, Helsinki University Central Hospital, Department of Medicine, Division of Endocrinology
ClinicalTrials.gov Identifier: NCT00575835     History of Changes
Other Study ID Numbers: 77/2006
Study First Received: December 17, 2007
Last Updated: December 26, 2007
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
vitamin D
seasonal variation
PTH
bone markers

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014