Vitamin D Supplementation in Younger Women (VITADAS)
Primary Purpose
Hypovitaminosis D
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin D3
Sponsored by
About this trial
This is an interventional health services research trial for Hypovitaminosis D focused on measuring Vitamin D insufficiency,vitamin D3 treatment,young women
Eligibility Criteria
Inclusion Criteria:
- Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
- Serum 25OHD level: 5 - 20 ng/ml
- BMI < 45 kg/m2.
- Willing to discontinue vitamin D supplements after entering the study.
- Negative pregnancy test before BMD and calcium absorption tests.
- Willing to give signed informed consent form
- Subject is Caucasian or African American
Exclusion Criteria:
- Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
- Previous hip fracture.
- Hemiplegia.
- Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar >140 mg in type II diabetes.
- Kidney stones- > 2 in a lifetime.
- Chronic renal failure (serum creatinine >1.4 mg/dl).
- 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 (except birth control pills).
- Chronic high dose corticosteroid therapy (> 10 mg/day) for over 6 months and not within the last 6 months.
- Anticonvulsant therapy. (Dilantin, Phenobarbital)
- High dose thiazide therapy (> 37.5 mg).
- 24 hour urine calcium > 290 mg on 2 baseline tests.
- Serum calcium exceeding upper normal limit on 2 baseline tests.
- BMD. T-score less than -3.0 for spine or hip.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
A1 vitamin D3 400IU
A2 vitamin D3 800IU
A3 vitamin D3 1600IU
A4 Vitamin D3 2400 IU
Placebo
Arm Description
Orally for one year
Orally for one year
Orally for one year
Orally for one year
Placebo for one year
Outcomes
Primary Outcome Measures
Serum 25hydroxyvitamin D
Parathyroid hormone
Secondary Outcome Measures
serum and urine calcium
calcium absorption
radioactive calcium absorption is measured at baseline and end of study
Bone density
bone density
physical performance battery
Forced Expiratory Volume FEV1
spirometry
bone markers
serum osteocalcin,serum N-telopeptides
Serum 1,25-dihydroxyvitamin D3
serum test
skin color
measurement of sin color through the study using an IMS smart probe
Serum 24,25dihydroxyvitamin D
measurement of serum 24,24(OH)2D by LCMS( liquid chromatography mass spectrophotometry
Full Information
NCT ID
NCT00662844
First Posted
April 17, 2008
Last Updated
March 24, 2016
Sponsor
Creighton University
Collaborators
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT00662844
Brief Title
Vitamin D Supplementation in Younger Women
Acronym
VITADAS
Official Title
Optimum Vitamin D Nutrition in Young Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
University of Nebraska
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
That on average it will require a vitamin D dose of 1700IU/day to increase the serum 25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to 2480 IU/day in African American
Detailed Description
Vitamin D is a unique nutrient in that its requirement can be met by both endogenous production from sun and from diet, which makes it difficult to determine the actual requirements as for other nutrients. The current recommended dietary reference intake (DRI) for vitamin D is 200 IU for adults between 25- 50 years, 400 IU for adults between 51-70 years and 600 IU for adults 70 years of age. In view of many scientists in the field of vitamin D, the current DRI of vitamin D is too low. This is mainly because of the increase in prevalence of vitamin D deficiency observed in the population based on measured serum 25OHD levels. It is now recognized that serum 25OHD is an indicator of vitamin D status. There is a growing consensus that serum 25OHD concentration of at least 30-32 ng/ml are needed to reduce serum Parathyroid hormone (PTH) and reduce bone loss. Also, research over the last two decades has provided additional evidence that higher vitamin D levels (25OHD 30ng/ml) are necessary for optimum overall health and prevent disease. There is no clear view of the amount of vitamin D intake required to maintain the optimum level of serum 25OHD levels in the population of all ages and there are no systematic dose response studies of vitamin D in women of all ages. A few studies carried out with different sexes and age groups have suggested that an untreated subject with a serum 25OHD concentration of 20 ng/ml would need a daily dose of ~1700 IU/d of Vitamin D3 to reach a serum 25OHD of 32 ng/ml in Caucasians, while in African Americans the Vitamin D3 requirement would be higher - 1860-2480 IU/d.
The current proposal aims at studying the dose response effect of vitamin D3 400 IU, 800 IU,1600 IU and 2400 IU or placebo on serum 25OHD and serum PTH in young women with vitamin D insufficiency (serum 25OHD <20 ng/ml) and an adequate calcium intake of 1000mg/day.
Another aim of the study is to establish the minimum effective dose of vitamin D3 which Normalizes PTH in Caucasian and African American young women. Vitamin D dose that reduces serum PTH to normal level in 97% of normal population is the recommended dietary allowance.
We will also establish the safety of these higher doses of vitamin D supplementation relating to hypercalcemia/hypercalcuria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
Vitamin D insufficiency,vitamin D3 treatment,young women
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1 vitamin D3 400IU
Arm Type
Placebo Comparator
Arm Description
Orally for one year
Arm Title
A2 vitamin D3 800IU
Arm Type
Placebo Comparator
Arm Description
Orally for one year
Arm Title
A3 vitamin D3 1600IU
Arm Type
Placebo Comparator
Arm Description
Orally for one year
Arm Title
A4 Vitamin D3 2400 IU
Arm Type
Placebo Comparator
Arm Description
Orally for one year
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for one year
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
Calcium citrate (Citracal)
Intervention Description
Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1000-1200 mg/day
Primary Outcome Measure Information:
Title
Serum 25hydroxyvitamin D
Time Frame
Baseline, Change from Baseline at 6 Months and 12 Months
Title
Parathyroid hormone
Time Frame
Baseline, Change from Baseline at 6 Months and 12 Months
Secondary Outcome Measure Information:
Title
serum and urine calcium
Time Frame
Baseline, Change from Baseline at 6 Months, 9 Months and 12 Months
Title
calcium absorption
Description
radioactive calcium absorption is measured at baseline and end of study
Time Frame
Baseline, Change from Baseline at 12 Months
Title
Bone density
Description
bone density
Time Frame
Baseline, Change from Baseline at 12 Months
Title
physical performance battery
Time Frame
Baseline, Change from Baseline at 12 Months
Title
Forced Expiratory Volume FEV1
Description
spirometry
Time Frame
Baseline, Change from Baseline at 12 Months
Title
bone markers
Description
serum osteocalcin,serum N-telopeptides
Time Frame
Baseline, Change from Baseline at 12 Months
Title
Serum 1,25-dihydroxyvitamin D3
Description
serum test
Time Frame
Baseline, Change from Baseline at 12 Months
Title
skin color
Description
measurement of sin color through the study using an IMS smart probe
Time Frame
Baseline, Change from Baseline at 6 Months and 12 Months
Title
Serum 24,25dihydroxyvitamin D
Description
measurement of serum 24,24(OH)2D by LCMS( liquid chromatography mass spectrophotometry
Time Frame
Baseline, Change from Baseline at 12 Months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
Serum 25OHD level: 5 - 20 ng/ml
BMI < 45 kg/m2.
Willing to discontinue vitamin D supplements after entering the study.
Negative pregnancy test before BMD and calcium absorption tests.
Willing to give signed informed consent form
Subject is Caucasian or African American
Exclusion Criteria:
Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
Previous hip fracture.
Hemiplegia.
Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar >140 mg in type II diabetes.
Kidney stones- > 2 in a lifetime.
Chronic renal failure (serum creatinine >1.4 mg/dl).
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 (except birth control pills).
Chronic high dose corticosteroid therapy (> 10 mg/day) for over 6 months and not within the last 6 months.
Anticonvulsant therapy. (Dilantin, Phenobarbital)
High dose thiazide therapy (> 37.5 mg).
24 hour urine calcium > 290 mg on 2 baseline tests.
Serum calcium exceeding upper normal limit on 2 baseline tests.
BMD. T-score less than -3.0 for spine or hip.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J C Gallagher, MD
Organizational Affiliation
Creighton University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9525348
Citation
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. doi: 10.1359/jbmr.1998.13.3.475.
Results Reference
background
PubMed Identifier
16960175
Citation
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. doi: 10.1093/ajcn/84.3.602.
Results Reference
background
PubMed Identifier
15797954
Citation
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. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.
Results Reference
background
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Vitamin D Supplementation in Younger Women
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