The Effect of Calcium Intake on Calcium and Bone Metabolism During Load Carriage in Women

Calcium Deficiency Clinical Trial

— En-Bone  

Official title:

The Effect of Calcium Intake on Calcium and Bone Metabolism During Load Carriage in Women: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823156
• Other study ID #: 1021/MODREC/19
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: May 19, 2023

Study information

• Verified date: April 2023
• Source: Army Health Branch, British Army
• Contact: Thomas J O'Leary, PhD
• Email: thomas.oleary100[@]mod.gov.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised trial will investigate the effect of calcium supplementation on bone and calcium metabolism in women during acute load carriage exercise. This study will test the hypothesis that calcium supplementation before load carriage exercise will attenuate the decline in serum ionised calcium and increase in parathyroid hormone and bone resorption.

Description:

Endurance exercise decreases serum ionised calcium and increases parathyroid hormone and bone resorption. These disturbances to calcium homeostasis can be attenuated by calcium supplementation before exercise. Military field exercises are characterised by high exercising energy expenditures, restricted dietary intake, and prolonged periods of load carriage. These exercise and nutritional challenges can result in impaired bone turnover, a negative calcium balance, and an increased risk of stress fracture. It is unknown if military load carriage disturbs calcium homeostasis and whether calcium supplementation before exercise can attenuate this disturbance. This crossover randomised controlled trial will investigate the effect of acute calcium supplementation on bone and calcium metabolism in women during acute load carriage exercise. Each participant will complete two 2 h load carriage trials. The trials will be performed after either consuming 1000 mg of calcium one hour before or with no treatment. During each experimental trial blood and urine will be sampled for markers of bone and calcium metabolism. Primary Outcome: The absolute change in urine calcium balance (Ca44:Ca42) between pre- and post-load carriage will be compared between the non-supplemented (Control) and calcium supplemented trial (Supplement) using one-way ANCOVAs with pre-load carriage calcium balance (either as a ratio, or both the numerator and denominator) as the covariate, or a linear mixed model with the restricted maximum likelihood estimation to allow incorporation of incomplete data. Secondary Outcomes: Circulating measures of bone turnover and calcium metabolism during load carriage will be compared between Control and Supplement using linear mixed models with the restricted maximum likelihood estimation to allow incorporation of incomplete data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

1. Female sex;

2. Aged 18 to 36 years old;

3. Maximal rate of oxygen uptake of = 35 ml·kg-1·min-1;

4. Weight stable (no change in self-reported body mass = 5% over the previous 3 months);

5. BMI between 18 and 30 kg·m2;

6. Not pregnant.

Exclusion Criteria:

1. Evidence of disordered eating (= 20 on the EAT-26);

2. Self-reported change in body mass of = 5% over the previous 3 months;

3. Vitamin D deficient (total 25(OH)D < 30 nmol·L-1);

4. Maximal rate of oxygen uptake of < 35 ml·kg-1·min-1;

5. Total body BMD T-score of < -1;

6. Evidence of menstrual disturbance (oligomenorrhoea: < 9 menstrual cycles in previous 12 months or amenorrhoea: = 3 menstrual cycles in the previous 12 months);

7. Pregnant;

8. Current smoker, or stopped smoking within the last three months;

9. Taking any medications known to affect bone or calcium metabolism (e.g. treatment for thyroid disorders);

10. Self-declared history of heart, liver or kidney disease, diabetes or thyroid disorder;

11. Self-reported stress fracture or any other bone injuries in the previous 12 months;

12. Anaemia (haemoglobin <12 g·/dL-1).

13. Currently using the implant, injection, or the progesterone-only pill ('mini pill').

Related Conditions & MeSH terms

• Calcium Deficiency

Intervention

Dietary Supplement:
• Calcium
Daily calcium food supplement.

Locations

Country	Name	City	State
United Kingdom	Army Health and Performance Laboratory	Camberley	Surry

Sponsors (3)

Lead Sponsor	Collaborator
Army Health Branch, British Army	Osteolabs, GEOMAR, University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in muscle strength during load carriage.	Loss of muscle strength in the knee extensors and flexors measured by Biodex in response to load carriage exercise.	Before and immediately after exercise.
Primary	Change in calcium balance.	The ratio of the calcium isotopes Ca44:Ca42 in spot urine samples.	Before and immediately after exercise.
Secondary	Circulating calcium isotopes during load carriage.	The ratio of the calcium isotopes Ca44 and Ca42 (Ca44:Ca42) in blood.	Before and immediately after exercise.
Secondary	Bone turnover during load carriage.	Circulating concentration of procollagen type 1 N-terminal propeptide (P1NP), beta carboxy-terminal cross-linking telopeptide of type 1 collagen (ßCTX), osteocalcin, and sclerostin.	0, 20, 40, 60, 80, 100, and 120 minutes during, and 15, 30, 60 and 90 minutes following, exercise.
Secondary	Calcium metabolism during load carriage.	Circulating concentration of ionized calcium, phosphate, and intact parathyroid hormone.	0, 20, 40, 60, 80, 100, and 120 minutes during, and 15, 30, 60 and 90 minutes following, exercise.
Secondary	Dermal calcium loss.	Concentrations of total calcium and the ratio of the calcium isotopes Ca44 and Ca42 (Ca44:Ca42) in sweat.	During exercise.