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The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - RENEW Acute Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550078
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 15, 2020
Sponsor:
Collaborators:
Zealand University Hospital
Arla Foods
University of Aarhus
Innovation Fund Denmark
Information provided by (Responsible Party):
Inge Tetens, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Dietary Supplement: Calcium Carbonate Dietary Supplement: Calcium Permeate Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded
Primary Purpose: Prevention
Official Title: The Postprandial Calcium Absorption of a Milk Derived Calcium Permeate - A Randomized Controlled Cross-over Meal Study
Actual Study Start Date : July 22, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Active Comparator: Calcium Carbonate
800 mg calcium as calcium carbonate in capsules consumed orally once with a standardized meal.
Dietary Supplement: Calcium Carbonate
Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.

Experimental: Calcium-enriched permeate
800 mg calcium as calcium permeate in capsules consumed orally once with a standardized meal.
Dietary Supplement: Calcium Permeate
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.
Other Name: Capolac

Placebo Comparator: Maltodextrin
0 mg calcium as placebo capsules with maltodextrin consumed orally once with a standardized meal.
Dietary Supplement: Placebo
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.




Primary Outcome Measures :
  1. Serum Ionized calcium concentration [ Time Frame: 3 months ]
    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).


Secondary Outcome Measures :
  1. Serum calcium concentration [ Time Frame: 3 months ]
    Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).

  2. Serum phosphate concentration [ Time Frame: 3 months ]
    Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is 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. Serum magnesium concentration [ Time Frame: 3 months ]
    Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).

  4. Serum PTH concentration [ Time Frame: 3 months ]
    Blood samples are collected 5 times during subjects three visits. At each visit one baseline measurement blood sample is collected, followed by measurement 60 minutes, 120 minutes, 240 minutes and 360 minutes after ingestion of study products (calcium carbonate, calcium permeat or placebo).

  5. Urinary calcium concentration [ Time Frame: 3 months ]
    Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)

  6. Urine phosphate concentration [ Time Frame: 3 months ]
    Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)

  7. Urine magnesium concentration [ Time Frame: 3 months ]
    Subjects are instructed in 24 hour urine collection for each visit. On visit days two spot-urine samples will be sent for analysis. Samples will be collected at baseline and 360 minutes after ingestion of study products (calcium carbonate, calcium permeate and placebo)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is >50 years and <65 years of age by the time of inclusion.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550078


Contacts
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Contact: Inge Tetens, Professor 004535332127 ite@nexs.ku.dk
Contact: Mette F Hitz, Doctor 004547322512 mefh@regionsjaelland.dk

Locations
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Denmark
Zealand University Hospital Recruiting
Køge, Denmark, 4600
Contact: Mette F Hitz, Doctor    004547322512    mefh@regionsjaelland.dk   
Contact: Majbritt H Hare, PhD student    0045407330001    mhh@nexs.ku.dk   
Sponsors and Collaborators
Inge Tetens
Zealand University Hospital
Arla Foods
University of Aarhus
Innovation Fund Denmark
Investigators
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Principal Investigator: Inge Tetens, Professor University of Copenhagen
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Responsible Party: Inge Tetens, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04550078    
Other Study ID Numbers: M235
First Posted: September 15, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents