Comparison of conventional dose with high dose vitamin D in osteoporotic or osteopenic (T Score < -1) women over 50 yrs referring to Shariati Hospital

High dose vitamin D supplement versus conventional dose in women over 50 years with osteoporosis and osteopenia (T Score < -1)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201106126780N1

Enrollment

Registered

2012-11-21

Start date

2008-09-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: osteoprosis. Condition 2: Vitamin D deficiency. Postmenopausal osteoporosis Vitamin D deficiency

Interventions

Intervention 1: 50,000u vitamin D3 pearl, weekly for 3 month then monthly for another 9 month. Intervention 2: control : 400 iu vitamin D3 tablet twice a day for one year.

Treatment - Drugs

Treatment - Other

50,000u vitamin D3 pearl, weekly for 3 month then monthly for another 9 month

control : 400 iu vitamin D3 tablet twice a day for one year

Eligibility

Sex/Gender

Female

Age

50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Outpatient women over 50 years old who have (T score< -1) in any site on their BMD at Shariati Hospital BMD laboratory. Exclusion Criteria: Vitamin D supplementation in the last 6 months; Glucocorticoid use in last 3 months; Use of Levothyroxine, anticonvulsant drugs, Lithium, Estrogen, Progesterone, Teriparatide, Cyclosporine; History of : Hyperparathyroidism, Hyperthyroidism, Romatoid Arthritis, Ancylosing Spondylitis, Malignancy, CKD (GFR<30), Premature Ovarian Failure.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum 25(OH) D level. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: ELISA kits Immunodiagnostic Systems Ltd (IDS), Boldon,UK with 5 nmol/L sensitivity.	—

Secondary

Measure	Time frame
Serum Ca. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: MTB assay, mg/dl.;Serum P. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: UV assay, mg/dl.;Serum PTH. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: ELISA kits Immunodiagnostic Systems Ltd (IDS), Boldon,UK , with 0/06 pmol/L sensitivity.;24 Hours Urine for Calcium. Timepoint: at base and 12th month. Method of measurement: MBT assay, mg/dl.	—

Measure

Time frame

Serum Ca. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: MTB assay, mg/dl.;Serum P. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: UV assay, mg/dl.;Serum PTH. Timepoint: at base, 3rd, 6th and 12th month. Method of measurement: ELISA kits Immunodiagnostic Systems Ltd (IDS), Boldon,UK , with 0/06 pmol/L sensitivity.;24 Hours Urine for Calcium. Timepoint: at base and 12th month. Method of measurement: MBT assay, mg/dl.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkbar Soltani

Endocrinology and Metabolism Research Institute

soltania@sina.tums.ac.ir+98 21 8026 9023

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026