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Effect of Vitamin D Replacement in Older People with Vitamin D Deficiency on Musculoskeletal Health, Metabolic Factors, Reproductive Hormone and Quality of life

Effect of Vitamin D Replacement in Older People with Vitamin D Deficiency on Musculoskeletal Health, Metabolic Factors, Reproductive Hormone and Quality of life

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210428006
Enrollment
210
Registered
2021-04-28
Start date
2021-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Vitamin D deficiency quality of life muscle strength metabolic vitamin D male reproductive hormone testosterone

Interventions

Group 1 will receive oral vitamin D3 20,000 IU per month (one tablet once a month) and calcium 600 mg daily for 12 months of study period. Group 2 will receive oral vitamin D3 20,000 IU per 2 weeks
Experimental Drug,Placebo Comparator No treatment
Vitamin D replacement,Control group

Sponsors

National Research Council of Thailand (NRCT)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Thai Nationality, Aged 60-90 years old who live in communities in Bangkok (2) Walking ability and self-care ability (3) Laboratory tests confirmed that vitamin D deficiency and 25 (OH) D level <30 ng / mL at screening

Exclusion criteria

Exclusion criteria: (1) Patients with disease that makes the limitation of daily activities and vigorous-intensity exercise including heart disease, respiratory diseases, severe hypertension (blood pressure was higher than 180/110 mmHg), Kidney disease (eGFR < 45 ml/min) (2) Have received supplement with vitamin D ongoing for 3 months prior to enrollment

Design outcomes

Primary

MeasureTime frame
Barthel Activities of Daily Living At 6 months and 12 months Change in Barthel ADL score at each time point,Quality of Life At 6 months and 12 months Change in EQ-5D-5L and WHOQOL score at each time point,Sleep Quality At 6 months and 12 months Change of Pittsburgh Sleep Quality score at each time point

Secondary

MeasureTime frame
Musculoskeletal Health At 6 months and 12 months Change in body composition at each point,Bone mineral content At 12 months Change in bone mineral content at each time point,Fall Rates At 6 months and 12 months Change in number of falls at each time point,25-hydroxy vitamin D At 6 months and 12 months Change in 25-hydroxy vitamin D levels at each time point,metabolic parameters At 6 months and 12 months Changes in metabolic parameters at each time point

Countries

Thailand

Contacts

Public ContactPetch Rawdaree

Navamindradhiraj University

petch1@nmu.ac.th0803029991

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026