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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
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
  2. Serum 25OHD level: 5 - 20 ng/ml
  3. BMI < 45 kg/m2.
  4. Willing to discontinue vitamin D supplements after entering the study.
  5. Negative pregnancy test before BMD and calcium absorption tests.
  6. Willing to give signed informed consent form
  7. Subject is Caucasian or African American

Exclusion Criteria:

  1. Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
  2. Previous hip fracture.
  3. Hemiplegia.
  4. Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar >140 mg in type II diabetes.
  5. Kidney stones- > 2 in a lifetime.
  6. Chronic renal failure (serum creatinine >1.4 mg/dl).
  7. Evidence of chronic liver disease, including alcoholism.
  8. Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity.
  9. Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide) or Fluoride in the last 6 months.
  10. Previous treatment within the last 6 months with calcitonin or estrogen (except birth control pills).
  11. Chronic high dose corticosteroid therapy (> 10 mg/day) for over 6 months and not within the last 6 months.
  12. Anticonvulsant therapy. (Dilantin, Phenobarbital)
  13. High dose thiazide therapy (> 37.5 mg).
  14. 24 hour urine calcium > 290 mg on 2 baseline tests.
  15. Serum calcium exceeding upper normal limit on 2 baseline tests.
  16. 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

    First Posted
    April 17, 2008
    Last Updated
    March 24, 2016
    Sponsor
    Creighton University
    Collaborators
    University of Nebraska
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    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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