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

NCT06900387 | Completed

• 1 other identifier: JCDC/BHR/23/044
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Does Vitamin D3 and Calcium supplementation improve the bone density on supplementation for the period of 6 months among post-menopausal women.

Conditions

Sarcopenia; Osteoporosis

Keywords

Sarcopenia intervention study; sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Vitamin D levels

  6 months.

• Parathyroid Hormone (PTH) levels

  6 months

• Lipid Profile

  6 months

Study Arms (3)

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.

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

Group B- Vitamin D3

ACTIVE COMPARATOR

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.

Group C- Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Interventions

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.

Group A- Calcium and Vitamin D3

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.

Group B- Vitamin D3

Control Group OTHER

No additional intervention was given to control group.

Group C- Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Anuradha Khadilkar: lead

Study Sites (1)

Hirabai Cowasji Jehangir Medical Research Institute, Jehangir Hospital, Pune

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Sarcopenia; Osteoporosis

Interventions

Cholecalciferol; Tablets; Control Groups

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dosage Forms; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: March 28, 2025
• Study Start: June 8, 2021
• Primary Completion: February 25, 2022
• Study Completion: September 23, 2022
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)