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临床试验/NCT06900387
NCT06900387已完成不适用

Effect of Oral Vitamin D3 and Calcium Supplementation on Sarcopenia Indices and Osteoporosis Among Rural Post-menopausal Women

Dr. Anuradha Khadilkar1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2021年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
1
主要终点
Sarcopenia Indices

研究概览

简要总结

This will be three-arm parallel group trial. The goal of this intervention study is to observe the effect of vitamin D3 and calcium supplementation for the period of 6 months on improving the sarcopenia indices such as appendicular muscle mass, muscle strength and muscle function as well as bone density among rural post-menopausal women between age 40 to 65 years. The main questions it aims to answer are:

  1. Does the Vitamin D3 supplementation alone help in improving sarcopenia measures or the addition of Calcium supplement along with Vitamin D3 will be more effective in improvement of muscle mass, muscle strength and muscle function.
  2. Does Vitamin D3 and Calcium supplementation improve the bone density on supplementation for the period of 6 months among post-menopausal women.

Participants will be given supplementation in three groups in which first group will receive vitamin D3 and calcium supplementation, second group will receive only vitamin D3 supplementation and third group will receive placebo in the form of vitamin B-Complex tablet. Calcium tablet of 500 mg was given daily for the period of 1 month and compliance was checked by collecting empty blisters of tablets from the participants. Vitamin D3 (60,000IU) tablet was given once a month and compliance were checked by observing direct consumption of tablet in front of the care provider/trained social worker. Participants will be measured at the baseline for their muscle and bone parameters and they will visit after 6 months on completion of their supplementation.

Researcher will compare both the supplementation arms (Calcium and vitamin D3 with vitamin D3 alone) with each other and with the third arm of placebo group (supplemented with vitamin B-complex tablet).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy post-menopausal women
  • •Age between 40-65 years.

排除标准

  • •Women with co-morbidities such as diabetes, thyroid conditions, heart disease, chronic liver/kidney disease, present acute illness
  • •Presence of any metal implants in bones
  • •Women who have undergone hysterectomy.

研究组 & 干预措施

Group A- Calcium and Vitamin D3

Active Comparator

Calcium Carbonate tablet (500 mg)- daily for the period of 6 months. Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months.

干预措施: Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month. (Dietary Supplement)

Group B- Vitamin D3

Active Comparator

Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months.

干预措施: Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month. (Dietary Supplement)

Group C- Control Group

Active Comparator

This was a control group. No additional intervention was given to control group.

干预措施: Control Group (Other)

结局指标

主要结局

Sarcopenia Indices

时间窗: 6 months

Change in appendicular skeletal muscle index, muscle strength and muscle function in post-menopausal women after supplementation with calcium and vitamin D3 using DXA, JAMAR hand dynamometer and Short Physical Performance Battery

Bone density measures

时间窗: 6 months

Change in bone mineral density at lumbar spine and femur neck in post-menopausal women after supplementation with calcium and vitamin D3 using DXA

次要结局

  • Vitamin D levels(6 months.)
  • Parathyroid Hormone (PTH) levels(6 months)
  • Lipid Profile(6 months)

研究者

发起方
Dr. Anuradha Khadilkar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Anuradha Khadilkar

Deputy Director

Hirabai Cowasji Jehangir Medical Research Institute

研究点 (1)

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