NCT02615301

Brief Summary

The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

November 18, 2015

Last Update Submit

November 24, 2015

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (7)

  • Bone-specific alkaline phosphatase

    Serum (µg/l)

    3 months

  • Osteocalcin

    Serum (ng/ml)

    3 months

  • Undercarboxylated osteocalcin (GLU)

    Serum (ng/ml)

    3 months

  • Carboxylated osteocalcine (GLA)

    Serum (ng/ml)

    3 months

  • GLU/GLA-ratio

    Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine

    3 months

  • N-telopeptides/creatinine

    Urinary (mmol/l)

    3 months

  • Deoxypyridinoline/creatinine

    Urinary (mmol/l)

    3 months

Secondary Outcomes (6)

  • 25-hyroxyvitamin D

    3 months

  • Eicosapentaenoic acids

    3 months

  • Docosahexaenoic acids

    3 months

  • Omega-3 index

    3 months

  • Body composition

    3 months

  • +1 more secondary outcomes

Study Arms (4)

Salmon (HD+HK)

EXPERIMENTAL

Tailor-made salmon with high levels of vitamin D3 and K1

Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and K1

Salmon (LD+HK)

EXPERIMENTAL

Tailor-made salmon with low levels of vitamin D3 and high K1

Dietary Supplement: Tailor-made salmon with low levels of vitamin D3 and high K1

Salmon (HD+LK)

EXPERIMENTAL

Tailor-made salmon with high levels of vitamin D3 and low K1

Dietary Supplement: Tailor-made salmon with high levels of vitamin D3 and low K1

Supplement (vitamin D + Calcium)

EXPERIMENTAL

Supplement with vitamin D and Calcium

Dietary Supplement: Supplement with vitamin D and Calcium

Interventions

Tailor-made salmon with high levels of vitamin D3 and K1DIETARY_SUPPLEMENT

The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.

Salmon (HD+HK)
Tailor-made salmon with low levels of vitamin D3 and high K1DIETARY_SUPPLEMENT

The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.

Salmon (LD+HK)
Tailor-made salmon with high levels of vitamin D3 and low K1DIETARY_SUPPLEMENT

The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.

Salmon (HD+LK)
Supplement with vitamin D and CalciumDIETARY_SUPPLEMENT

The aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.

Supplement (vitamin D + Calcium)

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postmenopausal women
  • Caucasian ethnicity
  • Age range 50-65 years
  • Having postmenopausal age of at least one year

You may not qualify if:

  • Osteoporotic fractures
  • Medical treatment for osteoporosis
  • Warfarin treatment
  • Creatinine above or below normal range
  • Hypervitaminosis D
  • Malabsorption syndrome
  • Inflammatory bowel disease
  • Inflammatory rheumatic diseases
  • Women who had planned to go away on holiday during the intervention could not participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIFES

Bergen, 5817, Norway

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Ingvild E Graff, PhD

    NIFES, postboks 2029 Nordnes, 5815 Bergen, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jannike Øyen, PhD

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 26, 2015

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 26, 2015

Record last verified: 2015-11

Locations

NO(1)