Trial Outcomes & Findings for Zinc & Bone Health in Thalassemia: The Think Zinc Study (NCT NCT00459732)

NCT ID: NCT00459732

Last Updated: 2020-12-04

Results Overview

Change in pa spine bone mineral density by DXA between baseline and 18 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 0 to 18 months
• Results posted on: 2020-12-04

Participant Flow

Subjects were recruited from 3 hematology clinics in the US between April, 2006 and May, 2008. 114 potentially eligible patients were screened, 43 were considered eligible and consented to participation.

Following enrollment, prior to group assignment, subjects were screened for copper and vitamin D status. If serum copper was <70ug/dL and/or 25OH vitamin D <20ng/mL, they were placed on daily supplementation, 2 mg Cu/day and/or 1000 IU vitamin D/day.

Participant milestones

Measure	Zinc 25 mg of zinc as zn sulfate taken daily	Placebo daily capsule similar in size/color to zn was taken daily by this group
Overall Study STARTED	23	17
Overall Study COMPLETED	19	14
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zinc & Bone Health in Thalassemia: The Think Zinc Study

Baseline characteristics by cohort

Measure	Zinc n=23 Participants 25 mg of zinc as zn sulfate taken daily	Placebo n=17 Participants daily capsule similar in size/color to zn was taken daily by this group	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	8 Participants n=7 Participants	21 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	17.7 years STANDARD_DEVIATION 5.6 • n=5 Participants	17.4 years STANDARD_DEVIATION 4.9 • n=7 Participants	17.6 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	17 participants n=7 Participants	40 participants n=5 Participants
Plasma Zinc	77 mcg/dL STANDARD_DEVIATION 11 • n=5 Participants	79 mcg/dL STANDARD_DEVIATION 14 • n=7 Participants	78 mcg/dL STANDARD_DEVIATION 12 • n=5 Participants
Spine Z-score	-1.9 Z-score STANDARD_DEVIATION 1.0 • n=5 Participants	-2.4 Z-score STANDARD_DEVIATION 1.1 • n=7 Participants	-2.1 Z-score STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: 0 to 18 months

Population: Intention to treat analysis of all subjects who completed the protocol in each arm of the study (zinc vs. placebo).

Change in pa spine bone mineral density by DXA between baseline and 18 months

Outcome measures

Measure	Zinc n=18 Participants 25 mg of zinc as zn sulfate taken daily	Placebo n=14 Participants daily capsule similar in size/color to zn was taken daily by this group
Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)	5.9 Percent Change Standard Deviation 5.3	1.5 Percent Change Standard Deviation 9.0

PRIMARY outcome

Timeframe: Baseline to 18 months

Population: Intention to treat analysis in those who completed the 18 month timepoint (zinc vs. placebo)

Outcome measures

Measure	Zinc n=17 Participants 25 mg of zinc as zn sulfate taken daily	Placebo n=14 Participants daily capsule similar in size/color to zn was taken daily by this group
Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)	6.1 Percent change Standard Deviation 6.1	2.2 Percent change Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline to 18 months

Population: Intention to treat analysis

Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups

Outcome measures

Measure	Zinc n=19 Participants 25 mg of zinc as zn sulfate taken daily	Placebo n=14 Participants daily capsule similar in size/color to zn was taken daily by this group
Osteocalcin, a Marker of Bone Formation	8.8 ng/mL Standard Deviation 17.1	-4.3 ng/mL Standard Deviation 23.2

Adverse Events

Zinc

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zinc n=19 participants at risk；n=23 participants at risk 25 mg of zinc as zn sulfate taken daily	Placebo n=14 participants at risk；n=17 participants at risk daily capsule similar in size/color to zn was taken daily by this group
Cardiac disorders Death	0.00% 0/23 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	5.9% 1/17 • Number of events 1 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.

Other adverse events

Measure	Zinc n=19 participants at risk；n=23 participants at risk 25 mg of zinc as zn sulfate taken daily	Placebo n=14 participants at risk；n=17 participants at risk daily capsule similar in size/color to zn was taken daily by this group
Gastrointestinal disorders Nausea	52.6% 10/19 • Number of events 14 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	57.1% 8/14 • Number of events 10 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.
Gastrointestinal disorders Diarrhea	15.8% 3/19 • Number of events 7 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	35.7% 5/14 • Number of events 7 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.
Gastrointestinal disorders Stomach Upset	57.9% 11/19 • Number of events 13 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	57.1% 8/14 • Number of events 11 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.
Blood and lymphatic system disorders Fatigue	26.3% 5/19 • Number of events 6 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	35.7% 5/14 • Number of events 6 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.
Nervous system disorders Headache	42.1% 8/19 • Number of events 9 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.	57.1% 8/14 • Number of events 9 • Recorded between baseline and 18 month time point (end of study) Adverse events were collected at 5 timepoints, 3, 6, 12 and 18 months after start of supplementation.

Additional Information

Ellen Fung, PhD RD CCD

Children's Hospital & Research Center, Oakland

Phone: 510-428-3885

Email: efung@mail.cho.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place