Trial Outcomes & Findings for Vitamin D Deficiency, Insulin Resistance and FGF-23 (NCT NCT00491322)

Last Updated: 2018-05-02

Results Overview

Fibroblast growth factor 23 (FGF23) is a phosphate and vitamin D regulating hormone.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-05-02

Subjects were enrolled from 2006-2008. Subjects were healthy volunteers recruited from the community

Participant milestones
Measure	Ergocalciferol Group Ergocalciferol 50000 international units once a week for 12 weeks	Placebo Group Matching placebo once a week for 12 weeks
Overall Study STARTED	41	51
Overall Study COMPLETED	40	50
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal
Measure	Ergocalciferol Group Ergocalciferol 50000 international units once a week for 12 weeks	Placebo Group Matching placebo once a week for 12 weeks
Overall Study Protocol Violation	1	0
Overall Study Pregnancy	0	1

Vitamin D Deficiency, Insulin Resistance and FGF-23

Baseline characteristics by cohort
Measure	Ergocalciferol Group n=40 Participants Ergocalciferol 50000 international units once a week for 12 weeks	Placebo Group n=50 Participants Matching placebo once a week for 12 weeks	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	50 Participants n=7 Participants	90 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 7 • n=5 Participants	29 years STANDARD_DEVIATION 9 • n=7 Participants	28 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	50 participants n=7 Participants	90 participants n=5 Participants

Timeframe: 12 weeks

Fibroblast growth factor 23 (FGF23) is a phosphate and vitamin D regulating hormone.

Outcome measures
Measure	Ergocalciferol Group n=40 Participants Participants receiving ergocalciferol 50000 units weekly for 12 weeks	Ergocalciferol Placebo Group n=50 Participants Participants receiving matching ergocalciferol placebo weekly for 12 weeks
Fibroblast Growth Factor 23 (FGF23) After 12 Weeks of Weekly Ergocalciferol 50000 Units	74 pg/mL Standard Deviation 42	39 pg/mL Standard Deviation 29

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Ergocalciferol Group n=40 participants at risk Ergocalciferol 50,000 international units once a week for 12 weeks	Placebo Group n=50 participants at risk Matching placebo once a week for 12 weeks
Endocrine disorders Asymptomatic hypocalcemia	0.00% 0/40 • 12 to 38 weeks Subjects were monitored during the12 weeks of the intervention at their baseline, week 4, week 8, and week 12 visits for adverse events. Subjects were counseled to contact us after study completion if they had any concerns. During the 26 weeks after study completion, no subject contact the investigative team with an adverse event or concern.	2.0% 1/50 • Number of events 1 • 12 to 38 weeks Subjects were monitored during the12 weeks of the intervention at their baseline, week 4, week 8, and week 12 visits for adverse events. Subjects were counseled to contact us after study completion if they had any concerns. During the 26 weeks after study completion, no subject contact the investigative team with an adverse event or concern.

Massachusetts General Hospital

Phone: 6177245594