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NCT Number: NCT06900387

Effect of Oral Vitamin D3 and Calcium Supplementation on Muscle and Bone Health Among Rural Post-menopausal Women

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).

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune

Pune, Maharashtra, 411001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.

Dietary Supplement

Oral Calcium Carbonate supplement 500 mg from La Renon Healthcare Pvt Ltd to be administered daily for the period of 6 months. Oral Vitamin D3 (Cholecalciferol) supplement 60,000 IU from Eris Lifesciences Ltd to be administered once a month for the period of 6 months.

Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.

Dietary Supplement

Oral Vitamin D3 (Cholecalciferol) supplement 60,000 IU from Eris Lifesciences Ltd to be administered once a month for the period of 6 months.

Control Group

Other

No additional intervention was given to control group.

Primary outcomes

  1. Sarcopenia Indices

    Time frame: 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

  2. Bone density measures

    Time frame: 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

Secondary outcomes

  1. Vitamin D levels

    Time frame: 6 months.

    Change in Serum vitamin D levels(ng/ml) will be assessed

  2. Parathyroid Hormone (PTH) levels

    Time frame: 6 months

    Change in PTH levels ( pg/ml ) will be assessed

  3. Lipid Profile

    Time frame: 6 months

    Change in total cholesterol, triglycerides, HDL, LDL and VLDL levels (mg/dl) will be assessed

Sponsors and collaborators

Lead sponsor

Dr. Anuradha Khadilkar

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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