Effect of Nutrition on Bone Metabolism as Assessed by 41Ca

NCT01910142 | Completed

• 1 other identifier: 8145
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to develop a technique based on a single dose of a calcium isotope, which enables to determine the effect of a nutritional intervention on bone calcium metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K will be applied in postmenopausal women. Treatment effects will be determined by the urinary excretion of the calcium isotope and related to classical bone markers.

Conditions

Osteoporosis

Keywords

bone metabolism

Outcome Measures

Primary Outcomes (1)

• urinary 41calcium excretion

  Urine is collected for measurement of 41Ca. The concentration change of 41Ca during the intervention period indicates the efficacy of the intervention.

  on study day numbers: 36, 71, 106, 113, 120, 127, 134, 141, 148, 155, 162, 169, 176, 183, 190, 197, 204, 211, 218, 225, 232, 239, 246, 253, 260, 267, 274, 281, 288

Secondary Outcomes (1)

• commonly accepted biomarkers for bone metabolism

  on study day numbers: 148, 183, 218, 253, 288

Study Arms (2)

calcium supplement with vitamin K

ACTIVE COMPARATOR

Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3 and 100 μg vitamin K. Additional 200 mg calcium in the form of carbonate

Dietary Supplement: vitamin K; Dietary Supplement: calcium

calcium supplement without vitamin K

PLACEBO COMPARATOR

Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3. no vitamin K. Additional 200 mg calcium in the form of carbonate

Dietary Supplement: calcium

Interventions

vitamin K DIETARY_SUPPLEMENT

A calcium product will be given either with or without vitamin K. Each intervention will last for 5 weeks, each followed by a 5 week wash-out. The first intervention will start about 4 months after inclusion and the single 41Ca bolus.

calcium supplement with vitamin K

calcium DIETARY_SUPPLEMENT

calcium supplement with vitamin K; calcium supplement without vitamin K

Eligibility Criteria

• Age: 50 Years - 68 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy as assessed by the
• health and lifestyle questionnaire,
• physical examination
• results of the pre-study laboratory tests
• Females aged 50-68 years at Day 01 of the study
• Relatively low calcium intake as assessed by dairy intake questionnaire
• Body Mass Index (BMI) \< 30 kg/m2
• Postmenopausal as confirmed by Follicle stimulating hormone (FSH) and oestradiol (E2) blood levels (FSH \> 40IU/L, E2 \< 70 pg/mL)
• Normal Dutch eating habits
• Voluntary participation
• Having given written informed consent
• Willing to comply with the study procedures
• Appropriate veins for blood sampling/cannula insertion according to TNO
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
• Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

You may not qualify if:

• Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
• Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
• Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension and gastrointestinal disease
• Prescribed medication, including hormone replacement therapy (within 6 months before start of the study) and anticoagulant medication.
• Reported intolerance for dairy products
• Not willing to stop the use of Boerenkarnemelk and cheese of the following Dutch brands: Emmenthaler, Gruyere, Leer/Maasdammer
• Alcohol consumption \> 21 units/week
• Not willing to stop use of supplements containing minerals or vitamins
• Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
• Reported slimming or medically prescribed diet
• Reported vegan, vegetarian or macrobiotic
• Recent blood donation (\<1 month prior to the start of the study)
• Not willing to give up blood donation during the study.
• Personnel of TNO Quality of Life, their partner and their first and second degree relatives
• Not having a general practitioner

Sponsors & Collaborators

• TNO: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

Vitamin K; Calcium

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Gertruud C Bakker, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: July 29, 2013
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 29, 2013

Record last verified: 2013-07