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Oral Vitamin D Supplementation in Elderly Women

This study has been completed.
Päivikki and Sakari Sohlberg Foundation, Finland
Lilly Foundation
Information provided by:
Helsinki University Identifier:
First received: December 17, 2007
Last updated: December 26, 2007
Last verified: December 2007
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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

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


Ages Eligible for Study:   70 Years to 80 Years   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00575835

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

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

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

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017