The Effect of Calcium Intake on Calcium and Bone Metabolism During Load Carriage in Women
En-Bone
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2021
CompletedStudy Start
First participant enrolled
March 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2023
CompletedApril 21, 2023
April 1, 2023
1.2 years
July 7, 2020
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in calcium balance.
The ratio of the calcium isotopes Ca44:Ca42 in spot urine samples.
Before and immediately after exercise.
Secondary Outcomes (4)
Circulating calcium isotopes during load carriage.
Before and immediately after exercise.
Bone turnover during load carriage.
0, 20, 40, 60, 80, 100, and 120 minutes during, and 15, 30, 60 and 90 minutes following, exercise.
Calcium metabolism during load carriage.
0, 20, 40, 60, 80, 100, and 120 minutes during, and 15, 30, 60 and 90 minutes following, exercise.
Dermal calcium loss.
During exercise.
Other Outcomes (1)
Change in muscle strength during load carriage.
Before and immediately after exercise.
Study Arms (2)
Calcium Supplementation
EXPERIMENTAL1000 mg of calcium carbonate one hour before exercise
No Calcium Supplementation
NO INTERVENTIONNo calcium supplementation
Interventions
Eligibility Criteria
You may qualify if:
- Female sex;
- Aged 18 to 36 years old;
- Maximal rate of oxygen uptake of ≥ 35 ml∙kg-1∙min-1;
- Weight stable (no change in self-reported body mass ≥ 5% over the previous 3 months);
- BMI between 18 and 30 kg∙m2;
- Not pregnant.
You may not qualify if:
- Evidence of disordered eating (≥ 20 on the EAT-26);
- Self-reported change in body mass of ≥ 5% over the previous 3 months;
- Vitamin D deficient (total 25(OH)D \< 30 nmol∙L-1);
- Maximal rate of oxygen uptake of \< 35 ml∙kg-1∙min-1;
- Total body BMD T-score of \< -1;
- Evidence of menstrual disturbance (oligomenorrhoea: \< 9 menstrual cycles in previous 12 months or amenorrhoea: ≤ 3 menstrual cycles in the previous 12 months);
- Pregnant;
- Current smoker, or stopped smoking within the last three months;
- Taking any medications known to affect bone or calcium metabolism (e.g. treatment for thyroid disorders);
- Self-declared history of heart, liver or kidney disease, diabetes or thyroid disorder;
- Self-reported stress fracture or any other bone injuries in the previous 12 months;
- Anaemia (haemoglobin \<12 g∙/dL-1).
- Currently using the implant, injection, or the progesterone-only pill ('mini pill').
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Army Health Branch, British Armylead
- University of East Angliacollaborator
- Osteolabs, GEOMARcollaborator
Study Sites (1)
Army Health and Performance Laboratory
Camberley, Surry, GU15 4PQ, United Kingdom
Related Publications (2)
Coombs CV, Greeves JP, Young CD, Irving AS, Eisenhauer A, Kolevica A, Heuser A, Tang JCY, Fraser WD, O'Leary TJ. The effect of calcium supplementation on bone calcium balance and calcium and bone metabolism during load carriage in women: a randomized controlled crossover trial. J Bone Miner Res. 2025 Jun 3;40(6):753-765. doi: 10.1093/jbmr/zjaf004.
PMID: 39804018DERIVEDCoombs CV, Wardle SL, Shroff R, Eisenhauer A, Tang JCY, Fraser WD, Greeves JP, O'Leary TJ. The effect of calcium supplementation on calcium and bone metabolism during load carriage in women: protocol for a randomised controlled crossover trial. BMC Musculoskelet Disord. 2023 Jun 16;24(1):496. doi: 10.1186/s12891-023-06600-w.
PMID: 37328859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Calcium supplements will be provided open-label.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Higher Scientific Officer
Study Record Dates
First Submitted
July 7, 2020
First Posted
March 30, 2021
Study Start
March 24, 2022
Primary Completion
May 19, 2023
Study Completion
May 19, 2023
Last Updated
April 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
Data will be owned by UK Ministry of Defence, not the Principal Investigator. Data will be made available where possible by the Principal Investigator assuming the appropriate approvals are granted by the UK Ministry of Defence.