Trial Outcomes & Findings for Impact of Vitamin D Supplementation on Lactation Associated Bone Loss (NCT NCT00903344)

NCT ID: NCT00903344

Last Updated: 2014-08-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Change from Baseline to 6 months
• Results posted on: 2014-08-18

Participant Flow

Participant milestones

Measure	Vitamin D - Experimental 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Overall Study STARTED	12	10
Overall Study 3 Month Visit	10	10
Overall Study 6 Month Visit	9	10
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	Vitamin D - Experimental 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Overall Study Pregnancy	2	3
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Baseline characteristics by cohort

Measure	Vitamin D - Experimental n=12 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=10 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily	Total n=22 Participants Total of all reporting groups
Age, Continuous	29 years STANDARD_DEVIATION 6 • n=5 Participants	32 years STANDARD_DEVIATION 3 • n=7 Participants	30 years STANDARD_DEVIATION 4.64 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 6 months

Outcome measures

Measure	Vitamin D - Experimental n=9 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=10 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in Bone Mineral Density (BMD) in HIP at 6 Months	-0.041 grams/cm^2 Standard Deviation 0.014	0.011 grams/cm^2 Standard Deviation 0.122

SECONDARY outcome

Timeframe: Change from Baseline to 3 Months

Population: At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results.

Difference in means between visits

Outcome measures

Measure	Vitamin D - Experimental n=10 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=8 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in 25-hyroxyvitamin D Levels at 3 Months	2.600 ng/ml Standard Deviation 7.230	-5.850 ng/ml Standard Deviation 7.713

SECONDARY outcome

Timeframe: Change from Baseline to 6 Months

Outcome measures

Measure	Vitamin D - Experimental n=9 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=10 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in 25-hyroxyvitamin D Levels at 6 Months	1.889 ng/ml Standard Deviation 7.865	-3.200 ng/ml Standard Deviation 13.774

SECONDARY outcome

Timeframe: Change from Baseline to 3 months

Population: At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.

Outcome measures

Measure	Vitamin D - Experimental n=10 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=9 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in Bone Mineral Density (BMD) at HIP at 3 Months	-0.017 grams/cm^2 Standard Deviation 0.009	-0.016 grams/cm^2 Standard Deviation 0.022

SECONDARY outcome

Timeframe: Change from Baseline to 3 Months

Population: At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.

difference in mean

Outcome measures

Measure	Vitamin D - Experimental n=10 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=9 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months	-0.025 grams/cm^2 Standard Deviation 0.071	-0.025 grams/cm^2 Standard Deviation 0.030

SECONDARY outcome

Timeframe: Change from Baseline to 6 Months

difference in the mean

Outcome measures

Measure	Vitamin D - Experimental n=9 Participants 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=10 Participants Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months	-0.060 grams/cm^2 Standard Deviation 0.036	-0.109 grams/cm^2 Standard Deviation 0.115

Adverse Events

Vitamin D - Experimental

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Multivitamin - Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin D - Experimental n=12 participants at risk 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily	Multivitamin - Active Comparator n=10 participants at risk Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
Gastrointestinal disorders Constipation	8.3% 1/12 • Number of events 1	0.00% 0/10

Additional Information

Dr. Leigh Eck

University of Kansas Medical Center

Phone: 913-588-6022

Email: leck2@kumc.edu

Results disclosure agreements

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