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

Dr. Anuradha Khadilkar

Status: Completed

Conditions: Osteoporosis; Sarcopenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06900387

JCDC/BHR/23/044

Details and patient eligibility

About

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).

Enrollment: 111 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

Group A- Calcium and Vitamin D3

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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

Treatment:

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

Group C- Control Group

Active Comparator group

Description:

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

Treatment:

Other: Control Group