Hypovitaminosis DVITADASNCT00662844
Vitamin D Supplementation in Younger Women
A study testing vitamin D3 in people with Hypovitaminosis D, run by Creighton University.
Trial 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 Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
About this study
Official title: Optimum Vitamin D Nutrition in Young Women
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
Read the 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.
- Conditions
- Hypovitaminosis D
- Being tested
- vitamin D3
- Keywords
- Vitamin D insufficiency,vitamin D3 treatment,young women
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Also called Calcium citrate (Citracal)
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
| Study group | Role | What they receive |
|---|---|---|
| A1 vitamin D3 400IU | Placebo comparator | Orally for one year Receives: Dietary Supplement: vitamin D3 |
| A2 vitamin D3 800IU | Placebo comparator | Orally for one year Receives: Dietary Supplement: vitamin D3 |
| A3 vitamin D3 1600IU | Placebo comparator | Orally for one year Receives: Dietary Supplement: vitamin D3 |
| A4 Vitamin D3 2400 IU | Placebo comparator | Orally for one year Receives: Dietary Supplement: vitamin D3 |
| Placebo | Placebo comparator | Placebo for one year Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25hydroxyvitamin D
Measured: Baseline, Change from Baseline at 6 Months and 12 Months
Parathyroid hormone
Measured: Baseline, Change from Baseline at 6 Months and 12 Months
Secondary outcomes (9)
serum and urine calcium
Measured: Baseline, Change from Baseline at 6 Months, 9 Months and 12 Months
calcium absorption
radioactive calcium absorption is measured at baseline and end of study
Measured: Baseline, Change from Baseline at 12 Months
Bone density
bone density
Measured: Baseline, Change from Baseline at 12 Months
physical performance battery
Measured: Baseline, Change from Baseline at 12 Months
Forced Expiratory Volume FEV1
spirometry
Measured: Baseline, Change from Baseline at 12 Months
bone markers
serum osteocalcin,serum N-telopeptides
Measured: Baseline, Change from Baseline at 12 Months
Serum 1,25-dihydroxyvitamin D3
serum test
Measured: Baseline, Change from Baseline at 12 Months
skin color
measurement of sin color through the study using an IMS smart probe
Measured: Baseline, Change from Baseline at 6 Months and 12 Months
Serum 24,25dihydroxyvitamin D
measurement of serum 24,24(OH)2D by LCMS( liquid chromatography mass spectrophotometry
Measured: Baseline, Change from Baseline at 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Sponsor
- Investigators
- J C Gallagher, MD, Principal investigator, Creighton University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662844
- Sponsor's protocol ID
- PR065013
- Other IDs
- DOD. CDMRP. W81XWH-07-1-0201
- Acronym
- VITADAS
- Status last verified
- Mar 2016
- First submitted
- 17 Apr 2008
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. doi: 10.1359/jbmr.1998.13.3.475.
PubMed 9525348Aloia 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.
PubMed 16960175Holick 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.
PubMed 15797954
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Vitamin D Nutrition in Young Women
- ClinicalTrials.gov ID
- NCT00662844
- Acronym / sponsor ID
- VITADAS / PR065013
- Conditions
- Hypovitaminosis D
- Keywords
- Vitamin D insufficiency,vitamin D3 treatment,young women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- Apr 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1 vitamin D3 400IU | Placebo comparator | Dietary Supplement: vitamin D3Orally for one year |
| A2 vitamin D3 800IU | Placebo comparator | Dietary Supplement: vitamin D3Orally for one year |
| A3 vitamin D3 1600IU | Placebo comparator | Dietary Supplement: vitamin D3Orally for one year |
| A4 Vitamin D3 2400 IU | Placebo comparator | Dietary Supplement: vitamin D3Orally for one year |
| Placebo | Placebo comparator | Dietary Supplement: vitamin D3Placebo for one year |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3Also: Calcium citrate (Citracal)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 | Dietary supplement | A1 vitamin D3 400IU, A2 vitamin D3 800IU, A3 vitamin D3 1600IU, A4 Vitamin D3 2400 IU, Placebo |
Primary outcome
Serum 25hydroxyvitamin D
Time frame: Baseline, Change from Baseline at 6 Months and 12 Months
Parathyroid hormone
Time frame: Baseline, Change from Baseline at 6 Months and 12 Months
9 secondary outcomes
serum and urine calcium
Time frame: Baseline, Change from Baseline at 6 Months, 9 Months and 12 Months
calcium absorption
Time frame: Baseline, Change from Baseline at 12 Months
Bone density
Time frame: Baseline, Change from Baseline at 12 Months
physical performance battery
Time frame: Baseline, Change from Baseline at 12 Months
Forced Expiratory Volume FEV1
Time frame: Baseline, Change from Baseline at 12 Months
bone markers
Time frame: Baseline, Change from Baseline at 12 Months
Serum 1,25-dihydroxyvitamin D3
Time frame: Baseline, Change from Baseline at 12 Months
skin color
Time frame: Baseline, Change from Baseline at 6 Months and 12 Months
Serum 24,25dihydroxyvitamin D
Time frame: Baseline, Change from Baseline at 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Background: PubMed 9525348Gallagher 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.
- Background: PubMed 16960175Aloia 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.
- Background: PubMed 15797954Holick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J C Gallagher, MD principal investigator
Creighton University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D3 in people with Hypovitaminosis D, run by Creighton University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25hydroxyvitamin D (time frame: Baseline, Change from Baseline at 6 Months and 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00662844, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.