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The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women (Vitamin D)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Signed Informed Consent.
  2. Female age 55-70
  3. At least 2 years past menopause
  4. 25(OH)D≤ 17.5nmol/L (≤7 ng/ml)

Exclusion Criteria:

1. Vitamin D levels > 30nmol/L in the past 2 years 2. Creatinine > 1.2%mg 3. Calcium ≥ 10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D treatment over 2 months in the past 2 years 6. BMI>35 or BMI<20 7. Menopause before age 45 8. Type 1 diabetes 9. Concomitant disease:

  1. Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)
  2. Rheumatoid arthritis
  3. Nephrotic syndrome
  4. Chronic renal failure
  5. Primary hyperparathyroidism
  6. Hyperthyroidism
  7. Malignancies excluding skin cancers (within the last 5 years)
  8. Kidney stones or history of renal colic 10. Medications:
  9. Steroids use (past or present)
  10. Anti rejection drugs in the last 5 years
  11. Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years
  12. Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)
  13. Post menopausal HRT (in the last 10 years)
  14. Aromatase inhibitors: Femara, Arimadex (past or present)
  15. Current use of PPIs (lanton, controloc, zoton, omepradex etc)
  16. Current or past use of anti depressant SSRI (favoxil,cipralex etc)

Sites / Locations

  • Soroka University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D treatment

Arm Description

We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.

Outcomes

Primary Outcome Measures

Change in BMD (Z score) following 10 months of vitamin D supplementation
Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment

Secondary Outcome Measures

To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.
Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment

Full Information

First Posted
September 24, 2012
Last Updated
April 3, 2019
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01694355
Brief Title
The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women
Acronym
Vitamin D
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and will cause low BMD estimation in DXA scan due to insufficient bone mineralization. We assume that among these postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD. According to the results, bisphosphonates therapy may be an unnecessary treatment. The objective of this study is to evaluate the impact of severe vitamin D deficiency and its correction on Bone Mineral Density (BMD) in postmenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D treatment
Arm Type
Experimental
Arm Description
We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Primary Outcome Measure Information:
Title
Change in BMD (Z score) following 10 months of vitamin D supplementation
Description
Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
Time Frame
10-14 months
Secondary Outcome Measure Information:
Title
To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.
Description
Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
Time Frame
10-14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent. Female age 55-70 At least 2 years past menopause 25(OH)D≤ 17.5nmol/L (≤7 ng/ml) Exclusion Criteria: 1. Vitamin D levels > 30nmol/L in the past 2 years 2. Creatinine > 1.2%mg 3. Calcium ≥ 10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D treatment over 2 months in the past 2 years 6. BMI>35 or BMI<20 7. Menopause before age 45 8. Type 1 diabetes 9. Concomitant disease: Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease) Rheumatoid arthritis Nephrotic syndrome Chronic renal failure Primary hyperparathyroidism Hyperthyroidism Malignancies excluding skin cancers (within the last 5 years) Kidney stones or history of renal colic 10. Medications: Steroids use (past or present) Anti rejection drugs in the last 5 years Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present) Post menopausal HRT (in the last 10 years) Aromatase inhibitors: Femara, Arimadex (past or present) Current use of PPIs (lanton, controloc, zoton, omepradex etc) Current or past use of anti depressant SSRI (favoxil,cipralex etc)
Facility Information:
Facility Name
Soroka University Medical Center
City
Be'er Sheva
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women

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