Oral Vitamin D Supplementation in Elderly Women - Full Text View

Sponsors and Collaborators:	Helsinki University Päivikki and Sakari Sohlberg Foundation Lilly Foundation
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00575835

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

MedlinePlus related topics: Calcium Dietary Supplements

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial

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
1: Active Comparator	Dietary Supplement: vitamin D twice daily Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
2: Experimental	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

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

Lilly Foundation

More Information

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

Keywords provided by Helsinki University:

vitamin D
seasonal variation
PTH
bone markers

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Ergocalciferols

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009