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

Effect of Oral Vitamin D3 and Calcium Supplementation on Sarcopenia Indices and Osteoporosis 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).

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis
• Intervention / Treatment: Dietary supplement: Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.; Dietary supplement: Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy post-menopausal women
2. Age between 40-65 years.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A- Calcium and Vitamin D3; 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.	Dietary supplement: Tablet Calcinum-Calcium Carbonate (500mg) daily and Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month.; 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.
Active Comparator: Group B- Vitamin D3; Vitamin D3 (Cholecalciferol) tablet (60,000 IU) once a month for the period of 6 months.	Dietary supplement: Tablet Tayo- Vitamin D3 (Cholecalciferol) (60,000 IU) once a month.; Oral Vitamin D3 (Cholecalciferol) supplement 60,000 IU from Eris Lifesciences Ltd to be administered once a month for the period of 6 months.
Active Comparator: Group C- Control Group; This was a control group. No additional intervention was given to control group.	Other: Control Group; No additional intervention was given to control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sarcopenia Indices	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	6 months
Bone density measures	Change in bone mineral density at lumbar spine and femur neck in post-menopausal women after supplementation with calcium and vitamin D3 using DXA	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D levels	Change in Serum vitamin D levels(ng/ml) will be assessed	6 months.
Parathyroid Hormone (PTH) levels	Change in PTH levels ( pg/ml ) will be assessed	6 months
Lipid Profile	Change in total cholesterol, triglycerides, HDL, LDL and VLDL levels (mg/dl) will be assessed	6 months

Collaborators and Investigators

• Sponsor: Dr. Anuradha Khadilkar

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; Sarcopenia intervention study
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Bone Diseases, Metabolic; Muscular Atrophy; Atrophy; Osteoporosis; Sarcopenia; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bone Density Conservation Agents; Micronutrients; Antacids; Vitamin D; Ergocalciferols; Vitamins; Calcium Carbonate; Cholecalciferol
• Other Study ID Numbers: JCDC/BHR/23/044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No