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

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. 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).

Conditions

• Sarcopenia
• Osteoporosis

Interventions

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.

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.

OTHER

Control Group

No additional intervention was given to control group.

Sponsors & Collaborators

• Dr. Anuradha Khadilkar

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-08

Primary Completion

2022-02-25

Completion

2022-09-23

Countries

• India

Study Locations