Trial to Assess Vitamin D Requirements in Lactating Women

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Vitamin D Insufficiency
• Interventions: Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium; Dietary Supplement: 20µg Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT01349127
• Lead Sponsor: University College Cork

Brief Summary

This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women and to ascertain whether vitamin D supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe the relationship between them. Information on maternal iPTH levels, anthropometry, diet and sun exposure will also be reported.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• Pregnant women intending to breast feed their infant for at least 12-weeks
• Pregnant women >20 weeks gestation
• Pregnant women >18 years of age
• Pregnant women in good general health

Exclusion Criteria

• Consumption of a vitamin D-containing supplement(>10µg/day) in the 3 months prior to commencing the trial
• Consumption of a vitamin D or calcium containing supplement during the 12- week trial
• Mothers taking a vacation to a sunny climate or using a solarium during the 12-week trial
• Mothers with pre-existing type 1 or type 2 diabetes
• Mothers with pre-existing hypertension
• Mothers with diagnosed hypercalcemia
• Mothers with diagnosed intestinal malabsorption conditions
• Mothers with multiple fetuses (e.g. twins)
• Consumption of medications known to interfere with vitamin D metabolism.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20µg Vitamin D3 + 500 mg Calcium	20µg Vitamin D3 + 500 mg Calcium	Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol) and one tablet of calcium carbonate containing 500mg of calcium.
20µg Vitamin D3	20µg Vitamin D3	Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
Placebo	Placebo	Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).

Primary Outcome Measures

Name	Time	Method
Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk	12 weeks	Baseline and endpoint serum 25(OH)D analysis in mothers (week 0 and week 12); baseline, week 4, week 8 and enpoint analysis of vitamin D3, D2 and 25(OH)D in expressed breast milk (hindmilk samples)

Secondary Outcome Measures

Name	Time	Method
Maternal serum iPTH	12 weeks	Baseline and endpoint PTH will be measured in mothers

Trial Locations

Locations (1)

School of Food & Nutritional Sciences, University College Cork,; 🇮🇪 Cork, Ireland