NCT04550078

Brief Summary

This is a randomized controlled cross-over meal study with the overall aim to investigate the postprandial calcium absorption from calcium permeate compared with calcium carbonate. The hypothesis is that the bioavailability of calcium permeate is equal to or higher than calcium carbonate. This will be investigated in a cross-over design with 10 postmenopausal women age 50-65 as subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 22, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

August 10, 2020

Last Update Submit

November 16, 2020

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Serum Ionized calcium concentration

    Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample will be collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).

    3 months

Secondary Outcomes (7)

  • Serum calcium concentration

    3 months

  • Serum phosphate concentration

    3 months

  • Serum magnesium concentration

    3 months

  • Serum PTH concentration

    3 months

  • Urinary calcium concentration

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Calcium Carbonate

ACTIVE COMPARATOR

800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.

Dietary Supplement: Calcium Carbonate

Calcium-enriched permeate

EXPERIMENTAL

800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.

Dietary Supplement: Calcium Permeate

Maltodextrin

PLACEBO COMPARATOR

0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.

Dietary Supplement: Placebo

Interventions

Calcium CarbonateDIETARY_SUPPLEMENT

Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.

Calcium Carbonate
Calcium PermeateDIETARY_SUPPLEMENT

Subjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning.

Also known as: Capolac
Calcium-enriched permeate
PlaceboDIETARY_SUPPLEMENT

Subjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning.

Maltodextrin

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has been menopausal for 2-5 years.
  • Subject willing and able to meet at University Hospital, Køge for three whole days in one month.
  • Subject is non-smoking or able not to smoke during clinic visits.
  • Subject with no history of osteoporotic fractures.
  • Subject is willing and able to provide written informed consent prior to participation.

You may not qualify if:

  • Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy.
  • Subject with vitamin D insufficiency defined as ≤50nmol/l.
  • Subject with an osteoporosis diagnosis.
  • Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
  • Subject with any serious illness e.g. cancer.
  • Subject with lactose intolerance.
  • Subject with celiac disease.
  • Known or suspected abuse of alcohol or recreational drugs.
  • Known or suspected hypersensitivity to trial products or related products.
  • Subject where it is not possible to obtain sufficient data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Inge Tetens, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blinded
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2020

First Posted

September 16, 2020

Study Start

July 22, 2020

Primary Completion

November 6, 2020

Study Completion

November 6, 2020

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)