Trial to Assess Vitamin D Requirements in Lactating Women

Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349127

Acronym

DMUMs

Enrollment

136

Registered

2011-05-06

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2017-05-04

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

Conditions

Vitamin D Deficiency, Vitamin D Insufficiency

Keywords

Vitamin D, Cholecalciferol, Nutrient requirements, Randomised Controlled Trial, Lactation, pregnancy, Cord blood, Human milk, serum 25-hydroxyvitamin D, deficiency, insufficiency, nutrition

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.

Interventions

DIETARY_SUPPLEMENT20µg Vitamin D3

20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.

DIETARY_SUPPLEMENT20µg Vitamin D3 + 500 mg Calcium

20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.

DIETARY_SUPPLEMENTPlacebo

One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Maternal serum iPTH	12 weeks	Baseline and endpoint PTH will be measured in mothers

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026