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

Phase 1

• Conditions: testosterone; Vitamin D deficiency; quality of life; muscle strength; metabolic; vitamin D; male reproductive hormone

• Registration Number: TCTR20210428006
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 210

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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