Vitamin D Supplementation in Older Women - Full Text View

Sponsor:	Creighton University
Collaborators:	National Institute on Aging (NIA) Office of Dietary Supplements (ODS) University of Nebraska
Information provided by (Responsible Party):	Creighton University
ClinicalTrials.gov Identifier:	NCT00472823

Purpose

The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.

Condition	Intervention
Osteoporosis Aging	Drug: Vitamin D3 Drug: Calcium Citrate (Citracal)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Determination of RDA for Vitamin D in Caucasian and African American Women

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Calcium Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Calcium gluconate Calcium citrate Vitamin D

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

Changes in Serum 25-hydroxyvitamin D (25OHD) and parathyroid hormone (PTH) levels [ Time Frame: Baseline, 6months,12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Calcium absorption [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
100mg calcium+ calcium45
Serum/urine calcium [ Time Frame: Baseline and every 3 months ] [ Designated as safety issue: Yes ]
Bone markers [ Time Frame: Baseline, and 12 months ] [ Designated as safety issue: No ]
Bone density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
spine,hip,total body,lateral
Muscle strength [ Time Frame: Baseline,6 months,12 months ] [ Designated as safety issue: No ]
leg strength( Cybex),timed up and go,hand grip,chair stand,gait speed,quiet stance,postural stability( biodex),standing balance
Falls [ Time Frame: Baseline and every 3 months ] [ Designated as safety issue: No ]
questionnaire
Pulmonary function studies [ Time Frame: baseline and final test ] [ Designated as safety issue: No ]
FEV1
Genotyping [ Time Frame: one time ] [ Designated as safety issue: No ]
Molecular studies of peripheral leucocytes [ Time Frame: baseline and final test ] [ Designated as safety issue: No ]
Adult Depression Score [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
questionnaire
Physical Activity Scale form ( PASE) [ Time Frame: baseline,6 months,12 months ] [ Designated as safety issue: No ]
questionnaire
sun exposure [ Time Frame: baseline and every 3 months ] [ Designated as safety issue: No ]
sun exposure form and skin color evaluation by a reflective meter (SmartProbe)
Basic metabolic panel [ Time Frame: baseline and every 3 months ] [ Designated as safety issue: No ]
serum 1,25 dihydroxyvitamin D [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
questionnaire

Enrollment:	260
Study Start Date:	April 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vitamin D3 400 IU daily vitamin D3 400 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 800 IU daily vitamin D3 800 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 1600 IU daily vitamin D3 1600 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 2400 IU daily vitamin D3 2400 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 3200 IU daily vitamin D3 3200 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 4000 IU daily vitamin D3 4000 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal
Experimental: vitamin D3 4800 IU daily vitamin D3 4800 IU daily	Drug: Vitamin D3 Orally for one year Drug: Calcium Citrate (Citracal) Orally for one year; dosage adjusted so that calcium intake is 1200-1400mg daily Other Name: Citracal

Show Detailed Description

Eligibility

Ages Eligible for Study:	57 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 7 years post-menopause
Serum 25OHD level 5 ng/ml to 20 ng/ml
BMI less than or equal to 40 kg/m2
Willing to discontinue multivitamins that contain vitamin D during the study

Exclusion Criteria:

Cancer (except basal cell carcinoma) or terminal illness
Previous hip fracture
Hemiplegia (paralysis of one side of the body)
Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
Kidney stones more than twice in a lifetime
Chronic renal failure
Evidence of chronic liver disease, including alcoholism
Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity
Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide or Fluoride) in the last 6 months
Previous treatment within the last 6 months with calcitonin or estrogen
Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months and not within the last 6 months
Anticonvulsant therapy
High dose thiazide therapy (more than 37.5 mg)
24 hour urine calcium greater than 290 mg on 2 baseline tests
Serum calcium exceeding upper normal limit on 2 baseline tests
Bone Mineral Density T-score less than -3.0 for spine or hip

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472823

Locations

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

National Institute on Aging (NIA)

Office of Dietary Supplements (ODS)

University of Nebraska

Investigators

Principal Investigator:

J C Gallagher, MD

Creighton University Medical Center

More Information

Publications:

Gallagher JC, Kinyamu HK, Fowler SE, Dawson-Hughes B, Dalsky GP, Sherman SS. Calciotropic hormones and bone markers in the elderly. J Bone Miner Res. 1998 Mar;13(3):475-82.

Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. Epub 2005 Mar 29.

Aloia JF, Talwar SA, Pollack S, Feuerman M, Yeh JK. Optimal vitamin D status and serum parathyroid hormone concentrations in African American women. Am J Clin Nutr. 2006 Sep;84(3):602-9.

Responsible Party:	Creighton University
ClinicalTrials.gov Identifier:	NCT00472823 History of Changes
Other Study ID Numbers:	AG0081, 1R01AG028168-01
Study First Received:	May 10, 2007
Last Updated:	September 27, 2011
Health Authority:	United States: Federal Government

Keywords provided by Creighton University:

cholecalciferol
vitamin D deficiency
bone density

dietary calcium
hypercalcemia
hypercalciuria

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Cholecalciferol
Vitamin D

Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012