Trial to Assess Vitamin D Requirements in Lactating Women (DMUMs)

University College Cork (UCC)

Status: Completed

Conditions: Vitamin D Deficiency; Vitamin D Insufficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: 20µg Vitamin D3; Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium

Study type: Interventional

Funder types: Other

Identifiers

NCT01349127

Cork Vitamin D 06/RD/C/533

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 3 patient groups, including a placebo group

20µg Vitamin D3

Active Comparator group

Description:

Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).

Treatment:

Dietary Supplement: 20µg Vitamin D3

20µg Vitamin D3 + 500 mg Calcium

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: 20µg Vitamin D3 + 500 mg Calcium

Placebo

Placebo Comparator group

Description:

Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).

Treatment:

Dietary Supplement: Placebo