Vitamin D supplementation in the obese

Vitamin D supplementation in the obese: a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38158659

Enrollment

Registered

2012-04-27

Start date

2011-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe obesity, vitamin D deficiency Nutritional, Metabolic, Endocrine Obesity

Interventions

Participants are allocated to the vitamin D supplementation (Caltrate®) arm if their serum 25-hydroxyvitamin D concentration is less than 50 nmol/L AND if they are willing to commence vitamin D supple

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years 2. Body mass index is greater than 40 kg/m2

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to the active substances or any of the excipients of Caltrate® 2. Known hypersensitivity to soya or to peanut 3. Stage 4 or Stage 5 chronic kidney disease (eGFR 2.6 mmol/L) 6. Pregnancy 7. Lactation 8. Psychotic mental illness 9. Inability to understand the participant information or to give informed consent 10. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial (e.g., severe chronic lung disease, terminal illness) 11. Participation in a clinical trial during the 12 weeks prior to study entry (i.e., prior to screening visit)

Design outcomes

Primary

Measure	Time frame
The change in the time taken to walk 500 m at a moderately intense pace measured at 6 weeks before treatment, 0 weeks before treatment and 12 weeks after treatment	—

Secondary

Measure	Time frame
Change in the: 1. Time taken to complete an Up And Go Test (UAG, timed 3 metre walk starting from and finishing in a seated position) 2. Time taken to rise from a chair five times 3. Ability to complete tests of standing balance 4. Grip strength 5. Scores on quality of life questionnaires (SF-36, EQ-5D, ESS) 6. Number of peripheral blood mononuclear cell subsets 7. Serum hormone, bone turnover marker and cytokine concentrations 8. Blood pressure 9. Weight 10. Physical activity level Measured at 6 weeks before treatment, 0 weeks before treatment and 12 weeks after treatment.	—

Measure

Time frame

Change in the: 1. Time taken to complete an Up And Go Test (UAG, timed 3 metre walk starting from and finishing in a seated position) 2. Time taken to rise from a chair five times 3. Ability to complete tests of standing balance 4. Grip strength 5. Scores on quality of life questionnaires (SF-36, EQ-5D, ESS) 6. Number of peripheral blood mononuclear cell subsets 7. Serum hormone, bone turnover marker and cytokine concentrations 8. Blood pressure 9. Weight 10. Physical activity level Measured at 6 weeks before treatment, 0 weeks before treatment and 12 weeks after treatment.

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026